Bmi

FDA UDI

Class I (US FDA UDI)

by Blake Manufacturing, Inc.

Identity

Trade Name: BMI FDA UDI
Generic Name: Wrist/hand orthosis FDA UDI
Device Name: Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Regular, Side: Left FDA UDI
Model / Reference: HTA-KH-RL FDA UDI
Description: Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Regular, Side: Left FDA UDI

Identifiers

Catalog Number: HTA-KH-RL FDA UDI
Primary DI / UDI-DI: G088HTAKHRL0 FDA UDI
FDA Product Code: ILH FDA UDI
GMDN Term: Wrist/hand orthosis 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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

Category: Wrist/hand orthosis

Bmi by Blake Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Wrist/hand orthosis.

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PROFIT — PANTYMED S.A. · Class I
ComfyHealth — Comfy Health Group Co., Ltd. · Class I
MECRON Wrist Guard L: 23 cm, U: uber 22 cm — Darco (Europe) GmbH · Class I
ComfyHealth — Comfy Health Group Co., Ltd. · Class I
SPLINT, WRIST, LACE-UP, RIGHT, LARGE — DARCO International, 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: Blake Manufacturing, Inc.

Sources (1)

FDA UDI 142c8209-5d6f-48a0-9735-5c2ee3a8391c 34 fields · synced Jun 6, 2026