Identity
- Trade Name
- Body Pro-Lok™ System FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(1), Type 2 Bridge(1), and Respiratory Plate(1) FDA UDI
- Model / Reference
- MTSBRT420 FDA UDI
- Description
- (53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(1), Type 2 Bridge(1), and Respiratory Plate(1) FDA UDI
Identifiers
- Catalog Number
- MTSBRT420 FDA UDI
- Primary DI / UDI-DI
- 00841439107621 FDA UDI
- FDA Product Code
- LNH FDA UDIIYE FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI892.5050 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™ System 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
K093738 also covers:
- AccuForm™ Cushion — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® Headrest — Medtec LLC
K111340 also covers:
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Platform — 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
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 |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI c593f009-55c8-4555-9e4e-32b73a272ae6 36 fields · synced Jun 6, 2026