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Vac-Lok™ Cushion

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Vac-Lok™ Cushion FDA UDI
Generic Name
Vacuum-mould patient positioning system FDA UDI
Device Name
Nylon bag (75 x 75cm, 20L) with indexing for arms-up positioning FDA UDI
Model / Reference
VLARM01FC FDA UDI
Description
Nylon bag (75 x 75cm, 20L) with indexing for arms-up positioning FDA UDI

Identifiers

Catalog Number
VLARM01FC FDA UDI
Primary DI / UDI-DI
00841439112137 FDA UDI
510(k) Number
K080072 FDA UDI
K180021 FDA UDI
K935300 FDA UDI
FDA Product Code
IYE FDA UDI
LNH FDA UDI
GMDN Term
Vacuum-mould patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
892.1000 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
MRI Safety
MR Conditional FDA UDI

Category: Vacuum-mould patient positioning system

Vac-Lok™ Cushion by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vacuum-mould patient positioning system.

Cleared under the same submission

K080072 also covers:

K180021 also covers:

K935300 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 9ba1bb56-d186-4f58-9b95-ab7cc84b5d5c 36 fields · synced Jun 8, 2026