Identity
- Trade Name
- Kerecis® SurgiBind™ FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/ FDA UDI
- Model / Reference
- 300 sq cm Fenestrated FDA UDI
- Description
- Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/ FDA UDI
Identifiers
- Catalog Number
- 50241G23D0D FDA UDI
- Primary DI / UDI-DI
- 05694310961974 FDA UDI
- 510(k) Number
- K202430 FDA UDI
- FDA Product Code
- OXH FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 300 Square centimeter FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Kerecis® SurgiBind™ by KERECIS hf. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
- Biodesign — COOK BIOTECH INCORPORATED · Class II
- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Meso BioMatrix® Acellular Peritoneum Matrix — DSM BIOMEDICAL, INC. · Class II
- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- Permacol — SOFRADIM PRODUCTION · Class II
- XENMATRIX — Davol Inc. · Class II
Cleared under the same submission
K202430 also covers:
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — KERECIS hf.
- Kerecis® SurgiBind™ — 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 II | Pending data |
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Manufacturer
- Manufacturer
- KERECIS hf.
Sources (1)
- FDA UDI c424481d-5c5f-4737-82b9-a896eddf79c8 38 fields · synced May 30, 2026