Donjoy

FDA UDI

Class I (US FDA UDI)

by Djo, Llc

Identity

Trade Name: DONJOY FDA UDI
Generic Name: Shoulder immobilizer/orthosis, reusable FDA UDI
Device Name: ULTRASLING II,AB,BLK,M FDA UDI
Model / Reference: 11-0450-3-06000 FDA UDI
Description: ULTRASLING II,AB,BLK,M FDA UDI

Identifiers

Primary DI / UDI-DI: 00888912014366 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

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: Shoulder immobilizer/orthosis, reusable

Donjoy 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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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 c7ddf486-9628-45c4-b144-57c0acfdaad2 33 fields · synced Jun 8, 2026