Identity
- Trade Name
- Kerecis® Shield® Adhesive FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/ FDA UDI
- Model / Reference
- 15mm Circular FDA UDI
- Description
- Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/ FDA UDI
Identifiers
- Catalog Number
- 50215H50B0D FDA UDI
- Primary DI / UDI-DI
- 05694310965187 FDA UDI
- 510(k) Number
- K213231 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- Animal-derived wound matrix dressing FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 15 Millimeter FDA UDI
Category: Animal-derived wound matrix dressing
Kerecis® Shield® Adhesive by KERECIS hf. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Animal-derived wound matrix dressing.
- PuraPly™ Antimicrobial XT Wound Matrix — ORGANOGENESIS INC. · Class I
- DermaCol/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC · U
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
- HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- Solventum™ Promogran™ — Solventum US LLC · U
- Simpurity — SAFE N SIMPLE LLC · U
- ProgenaMatrix — Progenacare Global, LLC · U
- INTEGRA® — Integra Lifesciences Corp. · U
Cleared under the same submission
K213231 also covers:
- Kerecis® Shield® Spiral — KERECIS hf.
- Kerecis® Shield™ Adhesive — KERECIS hf.
- Kerecis® Shield™ Adhesive — KERECIS hf.
- Kerecis® Shield™ Spiral — KERECIS hf.
- Kerecis® Shield™ Standard — KERECIS hf.
- Kerecis® SurgiClose® Silicone — KERECIS hf.
- Kerecis® SurgiClose® Silicone — KERECIS hf.
- Kerecis® SurgiClose® Silicone — KERECIS hf.
- Kerecis® SurgiClose® Silicone — KERECIS hf.
- Kerecis® SurgiClose® Silicone — KERECIS hf.
- Kerecis® SurgiClose® Silicone — KERECIS hf.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- KERECIS hf.
Sources (1)
- FDA UDI 368db16c-f515-47c4-9210-8a7d66da3a5a 38 fields · synced May 31, 2026