Keramatrix (Amino Acids, Hair Keratin) Not Applicable [Molecular Biologicals, Llc] -

KERAMATRIX (AMINO ACIDS, HAIR KERATIN) NOT APPLICABLE [MOLECULAR BIOLOGICALS, LLC]
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NDC	71474-303-01, 71474-303-05, 71474-303-10, 71474-303-50, 71474-303-51, 71474-303-55
Set ID	2a20cd23-bdcc-453e-a72c-de7c123b3db8
Category	PRESCRIPTION MEDICAL DEVICE LABEL
Packager	Molecular Biologicals, LLC
Generic Name
Product Class
Product Number
Application Number	FRO

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SPL UNCLASSIFIED SECTION

Wound Matrix

Rx Prescription Only
Single Use

STERILE R

C E
0 1 2 3
CAUTION

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician(or properly licensed Healthcare practitioner).
INDICATIONS FOR USE

Acute surgical wounds, donor sites/grafts, podiatric wounds, wound dehiscence, diabetic ulcers, traumatic wounds, first & second degree Burns, chronic vascular ulcers, venous ulcers, Pressure ulcers, partial & full thickness wounds.

SUGGESTED DIRECTIONS FOR USE

NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE

WOUND BED PREPARATION & APPLICATION	MATRIX CHANGES AND REAPPLICATIONS
Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue. Cut the dry keramatrix® sheet into a piece slightly larger than the outline of the wound area. If the wound is larger than a single sheet then multiple sheets may be used,overlapping edges as necessary. For a wound with a low-level of exudate hydrate the matrix by soaking it in sterile saline solution for 2 minutes prior to application. Place the edge of the sheet in contact with intact tissue and smooth the matrix so that it contacts the underlying wound bed. If multiple matrices are used, overlap adjoining sheets to provide coverage of the entire wound. Secure with the preferred method of fixation[steri-strips, sutures, staples, clips}. After application use an appropriate, non-adherent, occlusive secondary dressing to maintain a moist environment. Ensure the matrix is well restrained.	6. Change keramatrix® sheet as necessary every 4 to 5 days days or as determined by the healthcare provider. Do not remove existing gel or matrix areas. The matrix will caramelize into a gel and have a off white light brown color. 7. Once cleansed with Sterile Saline solution keramatrix may be reapplied. Ensure that there are no bleeding areas and that the wound edges are clean. 8. For a wound with a medium to high level of exudate, place the edge of the sheet in contact with intact tissue and smooth the so that it contacts the underlying wound bed. Small openings can be cut into the sheet prior to application to allow adequate drainage and ensure tissue matrix contact with the wound bed. 9. Carefully document healing progression using customary healing parameters. Proceed with reapplication of appropriate non-adherent occlusive secondary dressing and maintain a moist environment. 10. If infection, excessive redness, blistering or allergic reaction occurs the matrix material should be removed.

WOUND BED PREPARATION & APPLICATION

MATRIX CHANGES AND REAPPLICATIONS

Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue.
Cut the dry keramatrix® sheet into a piece slightly larger than the outline of the wound area. If the wound is larger than a single sheet then multiple sheets may be used,overlapping edges as necessary.
For a wound with a low-level of exudate hydrate the matrix by soaking it in sterile saline solution for 2 minutes prior to application.
Place the edge of the sheet in contact with intact tissue and smooth the matrix so that it contacts the underlying wound bed. If multiple matrices are used, overlap adjoining sheets to provide coverage of the entire wound. Secure with the preferred method of fixation[steri-strips, sutures, staples, clips}.
After application use an appropriate, non-adherent, occlusive secondary dressing to maintain a moist environment. Ensure the matrix is well restrained.

6.: Change keramatrix® sheet as necessary every 4 to 5 days days or as determined by the healthcare provider. Do not remove existing gel or matrix areas. The matrix will caramelize into a gel and have a off white light brown color.
7.: Once cleansed with Sterile Saline solution keramatrix may be reapplied. Ensure that there are no bleeding areas and that the wound edges are clean.
8.: For a wound with a medium to high level of exudate, place the edge of the sheet in contact with intact tissue and smooth the so that it contacts the underlying wound bed. Small openings can be cut into the sheet prior to application to allow adequate drainage and ensure tissue matrix contact with the wound bed.
9.: Carefully document healing progression using customary healing parameters. Proceed with reapplication of appropriate non-adherent occlusive secondary dressing and maintain a moist environment.
10.: If infection, excessive redness, blistering or allergic reaction occurs the matrix material should be removed.

CONTRAINDICATIONS

Any known sensitivity to keratin.
PRECAUTIONS

Do not reuse or re-sterilize. Do not use if package is open or unsealed. Use prior to expiration date.
STORAGE

Do not use if pouch has been opened or damaged. Should be stored at a clean, dry location at room temperature.

HOW SUPPLIED

keramatrix is supplied in a clear pouch with labelled unit cartons.

keramatrix 5cm ×5cm Individual unit	71474-303-05
keramatrix 5cm × 5cm Box of 5 units	71474-303-55
keramatrix 5cm × 5cm Box of 10 units	71474-303-51
keramatrix 10cm × 10cm Individual unit	71474-303-01
keramatrix 10cm × 10cm Box of 5 units	71474-303-50
keramatrix 10cm × 10cm Box of 10 units	71474-303-10

SPL UNCLASSIFIED SECTION

Manufactured for:
Molecular Biologicals, LLC
Pasadena, TX 77505 | 1-844-793-9933
By Keraplast Research Limited
Gerald St, Lincoln 7674 NZ
PRINCIPAL DISPLAY PANEL - 5 Matrix Package Box Label

For Wounds & Burns
Keramatrix®
Enriched With Bioactive Keratin

5x 5 Matrices
NDC 71474-303-50
10cm x 10cm (4" x 4")

LOT EXP1220G3

2020-12-31

CE
0123
STERILE R

Rx Only

replicine™

For Topical Use Only
Store in dry conditions between 0°
and 35°C (32° and 95° F).
Do not use if the packaging has been
damaged prior to use.
Sterility is guaranteed until the packaging
is first opened or damaged prior to use.
Do not reuse or resterilize.
See package insert for usage and
complete Prescribing Information.

MolecularBiologicals.com

MOLECULAR BIOLOGICALS

THE HEALING POWER OF NATURE

Manufactured for:
Molecular Biologicals, LLC
Pasadena, TX 77505

Manufactured by:
Keraplast Research Limited
Gerald St.
Lincoln, 7674
New Zealand (NZL)

INGREDIENTS AND APPEARANCE

KERAMATRIX
dressing, wound, drug not applicable

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:71474-303
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) (AMINO ACIDS, HAIR KERATIN - UNII:G46579QK1M)	AMINO ACIDS, HAIR KERATIN	100 mg

#	Item Code	Package Description
Packaging
1	NHRIC:71474-303-01	1 in 1 POUCH
1		1 in 1 PACKAGE; Type 0: Not a Combination Product
2	NHRIC:71474-303-50	5 in 1 BOX
2		5 in 1 PACKAGE; Type 0: Not a Combination Product
3	NHRIC:71474-303-10	10 in 1 BOX
3		10 in 1 PACKAGE; Type 0: Not a Combination Product
4	NHRIC:71474-303-05	1 in 1 POUCH
4		1 in 1 PACKAGE; Type 0: Not a Combination Product
5	NHRIC:71474-303-55	5 in 1 BOX
5		5 in 1 PACKAGE; Type 0: Not a Combination Product
6	NHRIC:71474-303-51	10 in 1 BOX
6		10 in 1 PACKAGE; Type 0: Not a Combination Product