Wrist W/Thumb - Premier Sm Rt

FDA UDI

Class I (US FDA UDI)

by Bird & Cronin, Llc

Identity

Trade Name: WRIST W/THUMB - PREMIER SM RT FDA UDI
Generic Name: Wrist immobilizer, single-use FDA UDI
Model / Reference: 50004562 FDA UDI

Identifiers

Primary DI / UDI-DI: 00610570111329 FDA UDI
FDA Product Code: IQI FDA UDI
GMDN Term: Wrist immobilizer, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

MRI Safety

MR Safe FDA UDI

Category: Wrist immobilizer, single-use

Wrist W/Thumb - Premier Sm Rt by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Wrist immobilizer, single-use.

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mBrace 4285 Wrist Support with Hook — Semler Technologies, Inc. · Class I
PRIMO WRIST W/THUMB BLK XS RT — BIRD & CRONIN, LLC · Class I
PERFORMANCE WRIST MD LT — BIRD & CRONIN, LLC · Class I
MKO WRIST W/THUMB 10.5" RT LG — BIRD & CRONIN, LLC · Class I
PREMIER WRIST W/THUMB LG LT — BIRD & CRONIN, LLC · 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: Bird & Cronin, Llc

Sources (1)

FDA UDI e7413c4a-9cb0-4fc5-bff4-35b70e84fb03 32 fields · synced Jun 8, 2026