Identity
- Trade Name
- WoundSeal® FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- WoundSeal® + Applicator FDA UDI
- Model / Reference
- NCW001 FDA UDI
- Description
- WoundSeal® + Applicator FDA UDI
Identifiers
- Catalog Number
- NCW001 FDA UDI
- Primary DI / UDI-DI
- 00834061000026 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Non-organic haemostatic agent 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
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
Category: Non-organic haemostatic agent
WoundSeal® by Biolife, L.l.c. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070520 also covers:
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
K080210 also covers:
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
- WoundSeal® — BIOLIFE, L.L.C.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolife, L.l.c.
Sources (1)
- FDA UDI 328c04d6-3c9e-4d84-9247-c9f023fcb4d7 37 fields · synced May 30, 2026