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Clamp

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Clamp FDA UDI
Generic Name
Radiological whole-body positioner FDA UDI
Device Name
Rails-Only System with Varian Exact (53cm) FDA UDI
Model / Reference
20SBRT0601 FDA UDI
Description
Rails-Only System with Varian Exact (53cm) FDA UDI

Identifiers

Catalog Number
20SBRT0601 FDA UDI
Primary DI / UDI-DI
00841439110317 FDA UDI
510(k) Number
K973842 FDA UDI
FDA Product Code
IXQ FDA UDI
GMDN Term
Radiological whole-body positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Dimensions & Sizes

Size
Width — 3.9 Centimeter FDA UDI
Length — 10.4 Centimeter FDA UDI

Clamp by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

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 342a5d00-d0ce-4515-b57f-5b373065c087 38 fields · synced Jun 1, 2026