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Rails-only System

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Rails-only System FDA UDI
Generic Name
Radiological whole-body positioner FDA UDI
Device Name
50cm Interloc® FDA UDI
Model / Reference
MTSBRT052 FDA UDI
Description
50cm Interloc® FDA UDI

Identifiers

Catalog Number
MTSBRT052 FDA UDI
Primary DI / UDI-DI
00841439107461 FDA UDI
510(k) Number
K111340 FDA UDI
K973842 FDA UDI
FDA Product Code
IYE FDA UDI
IXQ FDA UDI
LNH FDA UDI
GMDN Term
Radiological whole-body positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
892.1980 FDA UDI
892.1000 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

Dimensions & Sizes

Size
Width — 22.4 Inch FDA UDI
Length — 43 Inch FDA UDI

Rails-only System by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111340 also covers:

K973842 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 a69cbf54-3e9b-4c0c-9b59-2751c4e2ff0f 38 fields · synced May 31, 2026