← Back to catalogue

Clam-Lok™ Cushion

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref VLSBRT202FCModel Vac-Lok Cushions

by Medtec LLC

Identity

Trade Name
Clam-Lok™ Cushion FDA UDI
Generic Name
Vacuum-mould patient positioning system FDA UDI
Device Name
Nylon bag with indexing FDA UDI
Model / Reference
VLSBRT202FC EUDAMEDFDA UDI
Vac-Lok Cushions EUDAMED
Description
Nylon bag with indexing FDA UDI

Identifiers

Catalog Number
VLSBRT202FC FDA UDI
Primary DI / UDI-DI
00841439112113 EUDAMEDFDA UDI
Basic UDI-DI
8414391OC0018R01BQ EUDAMED
510(k) Number
K080072 FDA UDI
K111340 FDA UDI
K935300 FDA UDI
FDA Product Code
IYE FDA UDI
LNH FDA UDI
EMDN Code
Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
GMDN Term
Vacuum-mould patient positioning system FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
892.1000 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Clam-Lok™ Cushion by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Vacuum-mould patient positioning system.

Cleared under the same submission

K080072 also covers:

K111340 also covers:

K935300 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Medtec LLC

Sources (2)

  • FDA UDI 82689066-fc6d-4d24-bd59-81c12359c3a2 36 fields · synced Jun 18, 2026
  • EUDAMED 6a24a699-68cf-4941-8251-4e47e6ac8ac5 61 fields · synced Jun 18, 2026