| NDC | 58189-122-01, 58189-122-10, 58189-123-01, 58189-123-10, 58189-130-01, 58189-130-10, 58189-144-01, 58189-144-10, 58189-145-01, 58189-145-10 |
| Set ID | 91244d66-ed63-4a70-a1ce-e2b77a6b09e1 |
| Category | MEDICAL DEVICE |
| Packager | Alliqua Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | FRO |
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SPL UNCLASSIFIED SECTION
Apply as a single layer.
Overlay with conventional dressings.
SilverSeal® Hydrogel Dressing is intended for the management of wounds and to provide an antimicrobial barrier
Silverseal® Hydrogel is intended for the management of wounds and to provide an antimicrobial barrier
Applicable to:
Partial and full thickness ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.
Silverseal® Hydrogel Dressing contains approximately 1.5% X-Static® silver coated fiberAntibacterial activity was confirmed via in vitro studies of bacterial growth dressing.
To facilitate removal, moisten with sterile water.
Caution: federal law restricts this device to sale by or on the order at a licensed practitioner.
Use before expiration date.
- Principal Display Panel – 2” X 2” Dressing Box Label
- Principal Display Panel – 2” X 2” Dressing Pouch Label
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Principal Display Panel – 2” X 3” Dressing Box Label
NDC 58198-123-10
SILVER
SEAL®(01)10816789010027
HYDROGEL DRESSING
PRODUCT CODE
AB-200300-103
STERILE Contents: Ten (10) dressings
SINGLE USE ONLY 2” X 3” (5.1cm X 7.6cm)Manufactured by Aquamed Technologies Inc.
for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047www.Alliqua.com
- Principal Display Panel – 4” X 5” Dressing Box Label
- Principal Display Panel – 3” Circle Dressing Box Label
- Principal Display Panel – 3” Circle Dressing Pouch Label
-
Principal Display Panel – 4” X 4" Circle Dressing Box Label
NDC 58198-044-10 PRODUCT CODE
AB-400400-001
HYDRESSTM
(01)10816789010003
HYDROGEL DRESSING
STERILE Contents: Ten (10) Hydrogel Dressings
SINGLE USE ONLY 4” X 4” (10cm X 10cm)Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | Tel 855-425-5478 | www.Alliqua.com -
Principal Display Panel – 4” X 4" Circle Dressing Pouch Label
NDC 58198-044-10 PRODUCT CODE
AB-400400-001
HYDRESSTM
(01)00816789010006
HYDROGEL DRESSING
STERILE Contents: One (1) dressing
SINGLE USE ONLY 4” X 4” (10cm X 10cm)Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | Tel 855-425-5478 | www.Alliqua.com -
Principal Display Panel – 4” X 5” Dressing Box Label
NDC 58198-145-10
SILVER
SEAL®PRODUCT CODE
AB-400500-105(01)10816789010010
HYDROGEL DRESSING
STERILE Contents: Ten (10) dressings
SINGLE USE ONLY 4” X 5” (10cm X 12.7cm)Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | www.Alliqua.com -
Principal Display Panel – 4” X 5” Dressing Box Label
NDC 58198-145-01
SILVER
SEAL®PRODUCT CODE
AB-400500-105(01)00816789010013
HYDROGEL DRESSING
STERILE Contents: One (1) dressing
SINGLE USE ONLY 4” X 5” (10cm X 12.7cm)Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | www.Alliqua.com -
INGREDIENTS AND APPEARANCE
X-STATIC SILVERSEAL HYDROGEL DRESSING 4 X 5
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58189-145 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58189-145-10 10 in 1 CARTON 1 NHRIC:58189-145-01 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K040019 05/15/2013 X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 3
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58189-123 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58189-123-10 10 in 1 CARTON 1 NHRIC:58189-123-01 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K040019 05/15/2013 X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 2
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58189-122 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58189-122-10 10 in 1 CARTON 1 NHRIC:58189-122-01 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K040019 06/01/2013 X-STATIC SILVERSEAL HYDROGEL DRESSING 3
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58189-130 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58189-130-10 10 in 1 CARTON 1 NHRIC:58189-130-01 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K040019 06/01/2013 HYDRESS
dressing,wound,hydrophilicProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58189-144 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58189-144-10 10 in 1 CARTON 1 NHRIC:58189-144-01 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Exempt Device FRO 05/15/2013 Labeler - Alliqua Inc (872967679)
