Identity
- Trade Name
- StatSeal® FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- StatSeal® Disc X-treme FDA UDI
- Model / Reference
- DE021 FDA UDI
- Description
- StatSeal® Disc X-treme FDA UDI
Identifiers
- Catalog Number
- DE021 FDA UDI
- Primary DI / UDI-DI
- 00834061000217 FDA UDI
- 510(k) Number
- K130324 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Non-organic haemostatic agent FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not 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
Yes
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
- Outer Diameter — 5.04 Centimeter FDA UDI
StatSeal® by Biolife, L.l.c. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K130324 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 U | Pending data |
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Manufacturer
- Manufacturer
- Biolife, L.l.c.
Sources (1)
- FDA UDI a67b295b-16a6-493b-bcdb-1f5797eb4391 39 fields · synced May 30, 2026