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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
Ear wick, non-biodegradable FDA UDI
Device Name
NETWORK EAR WICK PEDIATRIC, 7MM X 12MM, SINGLE FOILED (500/SP) FDA UDI
Model / Reference
SS30301-C FDA UDI
Description
NETWORK EAR WICK PEDIATRIC, 7MM X 12MM, SINGLE FOILED (500/SP) FDA UDI

Identifiers

Catalog Number
SS30301-C FDA UDI
Primary DI / UDI-DI
30886158014332 FDA UDI
510(k) Number
K920357 FDA UDI
FDA Product Code
KCN FDA UDI
GMDN Term
Ear wick, non-biodegradable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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

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: Ear wick, non-biodegradable

Ultracell® by Beaver-Visitec International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ear wick, non-biodegradable.

Cleared under the same submission

K920357 also covers:

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 2547ac9a-ed0d-4314-bc65-644e5ed1c5d1 37 fields · synced Jun 7, 2026