Identity
- Trade Name
- Kerecis® GraftGuide™ Mano FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/ FDA UDI
- Model / Reference
- Size L, 196 sq cm Dorsum Right / Palmar Left Meshed 2:1 FDA UDI
- Description
- Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/ FDA UDI
Identifiers
- Catalog Number
- 50202N36D0D FDA UDI
- Primary DI / UDI-DI
- 05694310964012 FDA UDI
- 510(k) Number
- K190528 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
- Area/Surface Area — 196 Square centimeter FDA UDI
Category: Animal-derived wound matrix dressing
Kerecis® GraftGuide™ Mano 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
K190528 also covers:
- Kerecis® GraftGuide® — KERECIS hf.
- Kerecis® GraftGuide® — KERECIS hf.
- Kerecis® GraftGuide™ Mano — KERECIS hf.
- Kerecis® GraftGuide™ Mano — KERECIS hf.
- Kerecis® GraftGuide™ Mano — KERECIS hf.
- Kerecis® SurgiClose® — KERECIS hf.
- Kerecis® SurgiClose® — KERECIS hf.
- Kerecis® SurgiClose® — KERECIS hf.
- Kerecis® SurgiClose® — KERECIS hf.
- Kerecis® SurgiClose® — KERECIS hf.
- Kerecis® SurgiClose® — KERECIS hf.
- Kerecis® SurgiClose® — 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 292d825b-9252-42af-9f9e-3c33f52663f1 38 fields · synced May 30, 2026