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Ultracell®

FDA UDI

Class I (US FDA UDI)

by Beaver-Visitec International, Inc.

Identity

Trade Name
Ultracell® FDA UDI
Generic Name
ENT space-occupying dressing, human-derived FDA UDI
Device Name
SINUS SLIMPACK W/STRING- 3.5CM X 0.9CM X 1.2CM (20/SP) FDA UDI
Model / Reference
20211-C FDA UDI
Description
SINUS SLIMPACK W/STRING- 3.5CM X 0.9CM X 1.2CM (20/SP) FDA UDI

Identifiers

Catalog Number
20211-C FDA UDI
Primary DI / UDI-DI
30886158012444 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

Yes

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
Sterilization Method
Radiation Sterilization 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beaver-Visitec International, Inc.

Sources (1)

  • FDA UDI 50354c02-8e04-42bf-984d-a795524cf722 36 fields · synced Jun 1, 2026