Identity
- Trade Name
- PuraStat (1mL) FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- PuraStat Gel is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (1 mL). FDA UDI
- Model / Reference
- 621-061 FDA UDI
- Description
- PuraStat Gel is a hemostat for mild and moderate bleeding intended to be used in gastrointestinal surgery (1 mL). FDA UDI
Identifiers
- Catalog Number
- 621-061 FDA UDI
- Primary DI / UDI-DI
- 00860001820867 FDA UDI
- 510(k) Number
- K210098 FDA UDI
- FDA Product Code
- QAU FDA UDI
- GMDN Term
- Non-organic 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
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: Non-organic haemostatic agent
PuraStat (1mL) by 3-D Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210098 also covers:
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, Inc.
Sources (1)
- FDA UDI 432f88f1-b20a-41f7-8ffe-2c3b070556b3 35 fields · synced Jun 8, 2026