Identity
- Trade Name
- Suprello FDA UDI
- Generic Name
- Synthetic wound matrix dressing FDA UDI
- Model / Reference
- Dispenser Box (2 mL Pre-Filled Syringe + Applicator Tip) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850058790060 FDA UDI
- 510(k) Number
- K222025 FDA UDI
- FDA Product Code
- KGN FDA UDIMGQ FDA UDIFRO FDA UDI
- GMDN Term
- Synthetic wound matrix dressing FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Category: Synthetic wound matrix dressingSynthetic peptide haemostatic agent
Suprello by Gel4med, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic peptide haemostatic agent.
- PuraStat — 3-D Matrix Europe SAS · Class II
- PuraGel 5mL — 3-D Matrix, Inc. · Class II
- PuraGel 3mL — 3-D Matrix, Inc. · Class II
- G4Derm Plus Synthetic Wound Matrix — Gel4med, Inc. · U
- Suprello — Gel4med, Inc. · U
- Suprello — Gel4med, Inc. · U
- G4Derm Plus Synthetic Wound Matrix — Gel4med, Inc. · U
- G4Derm Plus Synthetic Wound Matrix — Gel4med, Inc. · U
Cleared under the same submission
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
- Gel4med, Inc.
Sources (1)
- FDA UDI 7b4e27e1-88e2-47a6-963a-baaad804fdbd 33 fields · synced May 30, 2026