Identity
- Trade Name
- Body Pro-Lok™ Bridge FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Body Pro-Lok™ Bridge FDA UDI
- Model / Reference
- MTSBRT031 FDA UDI
- Description
- Body Pro-Lok™ Bridge FDA UDI
Identifiers
- Catalog Number
- MTSBRT031 FDA UDI
- Primary DI / UDI-DI
- 00841439107362 FDA UDI
- FDA Product Code
- IYE FDA UDIIXQ FDA UDILNH FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1980 FDA UDI892.1000 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiological whole-body positioner
Body Pro-Lok™ Bridge by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiological whole-body positioner.
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Cleared under the same submission
K111340 also covers:
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Platform — Medtec LLC
- Body Pro-Lok™ System — Medtec LLC
- Clam-Lok™ Cushion — Medtec LLC
- Forehead Brace — Medtec LLC
- Lok-Bar™ — Medtec LLC
- Lok-Bar™ — Medtec LLC
- Lok-Bar™ — Medtec LLC
- ONEBridge™ — Medtec LLC
- ONEBridge™ — Medtec LLC
- ONEPlatform™ — Medtec LLC
K973842 also covers:
- Body Pro-Lok™ Platform — Medtec LLC
- Docking Station — Medtec LLC
- Docking Station — Medtec LLC
- Handle — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- Interface for Varian — Medtec LLC
- Interloc® Lok-Bar™ — Medtec LLC
- Patient Hand Grip — Medtec LLC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI 0683d774-258d-46b9-bada-4000e50bafe8 36 fields · synced May 30, 2026