Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Neurosurgical sponge FDA UDI
- Device Name
- Neuro Sponges FDA UDI
- Model / Reference
- 111-03/20 FDA UDI
- Description
- Neuro Sponges FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094111032 FDA UDI
- FDA Product Code
- GDY FDA UDI
- GMDN Term
- Neurosurgical sponge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4450 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neurosurgical sponge
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurosurgical sponge.
- FABCO — FIRST AID BANDAGE CO INC · U
- PILLING — TELEFLEX INCORPORATED · U
- Delicot — American Surgical Company, LLC · Class II
- Telfa — American Surgical Company, LLC · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- Delicot — American Surgical Company, LLC · Class II
- FABCO — FIRST AID BANDAGE CO INC · U
- ArmourSorb — American Surgical Company, LLC · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI 624f7488-aecf-4d2f-84fd-990156c6f6d3 33 fields · synced Jun 1, 2026