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Bear

FDA UDI

Class I (US FDA UDI)

by Bear-Ent, LLC

Identity

Trade Name
BEAR FDA UDI
Generic Name
Paranasal sinus irrigation/aspiration cannula FDA UDI
Device Name
Van Alyea Antrum Cannula w Thumb Plate, Light Curve FDA UDI
Model / Reference
1.12.50 FDA UDI
Description
Van Alyea Antrum Cannula w Thumb Plate, Light Curve FDA UDI

Identifiers

Catalog Number
1.12.50 FDA UDI
Primary DI / UDI-DI
G043112500 FDA UDI
FDA Product Code
KAM FDA UDI
GMDN Term
Paranasal sinus irrigation/aspiration cannula FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Paranasal sinus irrigation/aspiration cannula

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

Similar devices

Also classified as Paranasal sinus irrigation/aspiration cannula.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bear-Ent, LLC

Sources (1)

  • FDA UDI b1716b12-0621-4c7a-9a42-f6b9ef2fefd8 34 fields · synced Jun 1, 2026