Identity
- Trade Name
- DONJOY FDA UDI
- Generic Name
- Arm immobilizer FDA UDI
- Device Name
- ULTRASLING® PRO ER/IR 30, UNIVERSAL FDA UDI
- Model / Reference
- 11-0472-9 FDA UDI
- Description
- ULTRASLING® PRO ER/IR 30, UNIVERSAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446683674 FDA UDI
- FDA Product Code
- ILI FDA UDI
- GMDN Term
- Arm immobilizer 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Arm immobilizer
Donjoy by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arm immobilizer.
- MEDI — MEDI MANUFACTURING, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Elite Orthopaedics — ELITE ORTHOPAEDICS, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 87d499e9-9a0a-40d5-9e00-aea701052c7c 33 fields · synced Jun 8, 2026