Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, single-use FDA UDI
- Device Name
- GUNSLINGER II BRACE RT BLACK FDA UDI
- Model / Reference
- GS101R FDA UDI
- Description
- GUNSLINGER II BRACE RT BLACK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517556260 FDA UDI
- FDA Product Code
- MRI FDA UDI
- GMDN Term
- Shoulder immobilizer/orthosis, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Shoulder immobilizer/orthosis, single-use
Trulife by Trulife Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Trulife Limited
Sources (1)
- FDA UDI a0e242f0-2022-4360-9a30-65b46bb51ff6 33 fields · synced Jun 8, 2026