Exos

FDA UDI

Class I (US FDA UDI)

by Djo, Llc

Identity

Trade Name: EXOS FDA UDI
Generic Name: Hand/finger splint, reusable FDA UDI
Device Name: SHRT ARM FRACTURE BRACE, OPEN THUMB, PINK, RT, 1XS/PEDS FDA UDI
Model / Reference: 311-32-4444 FDA UDI
Description: SHRT ARM FRACTURE BRACE, OPEN THUMB, PINK, RT, 1XS/PEDS FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446153573 FDA UDI
FDA Product Code: IQI FDA UDI
GMDN Term: Hand/finger splint, reusable 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand/finger splint, reusable

Exos by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand/finger splint, reusable.

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Plastalume — BROWNMED, INC. · Class I
Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
MedTextile — Medtex Swiss Ltd · Class I
PERFORMANCE HEALTH — Asp Global, LLC · Class I
McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
Plastalume — BROWNMED, 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: Djo, Llc

Sources (1)

FDA UDI 572aee43-1ef0-47af-b2c3-ab8d9f9fc173 33 fields · synced Jun 1, 2026