Stat-A-Dyne WHFO

FDA UDI

Class I (US FDA UDI)

by Lantz Medical

Identity

Trade Name: Stat-A-Dyne WHFO FDA UDI
Generic Name: Hand orthosis FDA UDI
Device Name: Orthosis providing flexion and extension of wrist, hand, and finger FDA UDI
Model / Reference: WHFO FDA UDI
Description: Orthosis providing flexion and extension of wrist, hand, and finger FDA UDI

Identifiers

Catalog Number: WHFO FDA UDI
Primary DI / UDI-DI: B770WH0 FDA UDI
FDA Product Code: IQI FDA UDI
GMDN Term: 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Hand orthosis

Stat-A-Dyne WHFO by Lantz Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ORTHOSIS CARROT BLUE ODOR CONTROL 1 SIZE CS/6 KITS — AliMed, LLC · Class I
MyoPro — Myomo, Inc. · Class II

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: Lantz Medical

Sources (1)

FDA UDI 538e2f0a-b79e-4732-83d6-d9a2031c6e71 34 fields · synced May 30, 2026