Identity
- Trade Name
- PROCARE FDA UDI
- Generic Name
- Arm immobilizer FDA UDI
- Device Name
- DELUXE ARM SLING (S), HEALTH CARE EXP FDA UDI
- Model / Reference
- 79-84003-0213 FDA UDI
- Description
- DELUXE ARM SLING (S), HEALTH CARE EXP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446154891 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arm immobilizer
A comprehensive, non-rigid device used to temporarily render the arm immovable at the shoulder and elbow for support of healing of an injury or surgical wound. It is a reusable device.
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 |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 64ea4b22-dcc4-4864-af60-d686db79918f 33 fields · synced Jul 19, 2026