Identity
- Trade Name
- PuraStat FDA UDI
- Generic Name
- Synthetic peptide haemostatic agent FDA UDI
- Model / Reference
- 621-035 FDA UDI
Identifiers
- Catalog Number
- 621-062 FDA UDI
- Primary DI / UDI-DI
- 04560436590354 FDA UDI
- FDA Product Code
- QAU FDA UDIPHN FDA UDI
- GMDN Term
- Synthetic peptide haemostatic agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4456 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
Category: Synthetic peptide haemostatic agent
PuraStat by 3-D Matrix Europe SAS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Synthetic peptide haemostatic agent.
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- PuraGel 5mL — 3-D Matrix, Inc. · Class II
- G4Derm Plus Synthetic Wound Matrix — Gel4med, Inc. · U
- PuraGel 3mL — 3-D Matrix, Inc. · Class II
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
- 3-D Matrix Europe SAS
Sources (1)
- FDA UDI acc57dec-6181-430b-9c97-61821e14421d 33 fields · synced May 30, 2026