Bear

FDA UDI

Class I (US FDA UDI)

by Bear-Ent, LLC

Identity

Trade Name: BEAR FDA UDI
Generic Name: Middle ear pick FDA UDI
Device Name: Quesnel Ear Needle, Sh and Bl Tips, Straight FDA UDI
Model / Reference: 6.56.20 FDA UDI
Description: Quesnel Ear Needle, Sh and Bl Tips, Straight FDA UDI

Identifiers

Catalog Number: 6.56.20 FDA UDI
Primary DI / UDI-DI: G043656200 FDA UDI
FDA Product Code: JYT FDA UDI
GMDN Term: Middle ear pick FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Middle ear pick

Bear by Bear-Ent, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Middle ear pick.

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FENTEX — FENTEX medical GmbH · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Integra® — Integra LifeSciences Production Corporation · Class I
FENTEX — FENTEX medical GmbH · Class I
SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Novo Surgical — NOVO SURGICAL, 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: Bear-Ent, LLC

Sources (1)

FDA UDI 26b8be8c-bd55-4d97-81d4-723ac2b9608a 34 fields · synced May 31, 2026