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Body Pro-Lok™ System Lite

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Body Pro-Lok™ System Lite 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(2), Type 2 Bridge(2), and Type 3 Bridge(1) FDA UDI
Model / Reference
MTSBRT410 FDA UDI
Description
(53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), and Type 3 Bridge(1) FDA UDI

Identifiers

Catalog Number
MTSBRT410 FDA UDI
Primary DI / UDI-DI
00841439107614 FDA UDI
510(k) Number
K093738 FDA UDI
K111340 FDA UDI
FDA Product Code
LNH FDA UDI
IYE FDA UDI
GMDN Term
Radiological whole-body positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
892.5050 FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Safe FDA UDI

Body Pro-Lok™ System Lite by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093738 also covers:

K111340 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI b8bfdab4-c13b-40b1-80ec-1d02e0a53b52 37 fields · synced May 31, 2026