← Back to catalogue

Body Pro-Lok™ System

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

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(2), Type 2 Bridge(2), Type 3 Bridge(1), Shoulder Bridge 2(1), and Forehead Restraint(1) FDA UDI
Model / Reference
MTSBRT400 FDA UDI
Description
(53cm x 143cm) overlay with MR T-pin Lok-Bar™s(4), Type 1B Bridge(2), Type 2 Bridge(2), Type 3 Bridge(1), Shoulder Bridge 2(1), and Forehead Restraint(1) FDA UDI

Identifiers

Catalog Number
MTSBRT400 FDA UDI
Primary DI / UDI-DI
00841439107607 FDA UDI
510(k) Number
K093738 FDA UDI
K973842 FDA UDI
FDA Product Code
LNH FDA UDI
IXQ FDA UDI
GMDN Term
Radiological whole-body positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
892.1980 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 by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093738 also covers:

K973842 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI 444e1f6f-f9f3-417e-85aa-4d1d4ac5f10d 37 fields · synced May 31, 2026