Identity
- Trade Name
- Ultracell® FDA UDI
- Generic Name
- ENT space-occupying dressing, human-derived FDA UDI
- Device Name
- ***NON-STERILE*** CLASSIC NASAL PACK, 4.5 CM W/STRING 15MM THICK (500/SP) FDA UDI
- Model / Reference
- NS10100-C FDA UDI
- Description
- ***NON-STERILE*** CLASSIC NASAL PACK, 4.5 CM W/STRING 15MM THICK (500/SP) FDA UDI
Identifiers
- Catalog Number
- NS10100-C FDA UDI
- Primary DI / UDI-DI
- 30886158014721 FDA UDI
- FDA Product Code
- EMX FDA UDI
- GMDN Term
- ENT space-occupying dressing, human-derived FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT space-occupying dressing, human-derived
Ultracell® by Beaver-Visitec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT space-occupying dressing, human-derived.
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Beaver-Visitec International, Inc.
Sources (1)
- FDA UDI be70f0d5-56b7-44d5-9afe-36ee5e31e3d1 36 fields · synced May 30, 2026