Procare

FDA UDI

Class I (US FDA UDI)

by Djo, Llc

Identity

Trade Name: PROCARE FDA UDI
Generic Name: Shoulder immobilizer/orthosis, reusable FDA UDI
Device Name: ARM SLING, CTN/POLY UNIV FDA UDI
Model / Reference: 155-79-84300 FDA UDI
Description: ARM SLING, CTN/POLY UNIV FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446660354 FDA UDI
FDA Product Code: ILI FDA UDI
GMDN Term: Shoulder immobilizer/orthosis, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3640 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoulder immobilizer/orthosis, reusable

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

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Also classified as Shoulder immobilizer/orthosis, reusable.

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DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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Elite Orthopaedics — ELITE ORTHOPAEDICS, INC. · Class I
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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 e59e6789-6b7a-4c10-b5e2-e496b3d64261 33 fields · synced May 31, 2026