Identity
- Trade Name
- B-COOL TERI SHOULDER W/2 PKS FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, single-use FDA UDI
- Model / Reference
- 08143313 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570124787 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
- Not 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
B-Cool Teri Shoulder W/2 Pks by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bird & Cronin, Llc
Sources (1)
- FDA UDI 03630eae-c235-4d72-879c-559c2d489ebe 33 fields · synced May 30, 2026