Identity
- Trade Name
- B-COOL SHOULDER WRAP W/2,2.0 PK FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, single-use FDA UDI
- Model / Reference
- HM3322 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840314812643 FDA UDI
- FDA Product Code
- IME FDA UDI
- GMDN Term
- Shoulder immobilizer/orthosis, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Shoulder immobilizer/orthosis, single-use
B-Cool Shoulder Wrap W/2, 2.0 Pk by Hausmann Enterprises, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Shoulder immobilizer/orthosis, single-use.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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- MESH VELPEAU SHOULDER IMMOB LG — BIRD & CRONIN, LLC · 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
- Hausmann Enterprises, Llc
Sources (1)
- FDA UDI 5d23901a-f63c-4ff0-b27b-8d7a9ddae839 32 fields · synced Jun 8, 2026