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Uni-frame® Thermoplastic

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MTAPURModel Thermoplastic Devices

by Medtec LLC

Identity

Trade Name
Uni-frame® Thermoplastic FDA UDI
Generic Name
Patient positioning thermoplastic mould material FDA UDI
Device Name
Reloadable 25.4cm standard perforation thermoplastic (3.2mm) FDA UDI
Model / Reference
MTAPUR EUDAMEDFDA UDI
Thermoplastic Devices EUDAMED
Description
Reloadable 25.4cm standard perforation thermoplastic (3.2mm) FDA UDI

Identifiers

Catalog Number
MTAPUR FDA UDI
Primary DI / UDI-DI
10841439103804 EUDAMEDFDA UDI
Basic UDI-DI
8414391OC0003R01AA EUDAMED
510(k) Number
K080072 FDA UDI
K093738 FDA UDI
K933227 FDA UDI
FDA Product Code
LNH FDA UDI
IYE FDA UDI
EMDN Code
Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
GMDN Term
Patient positioning thermoplastic mould material FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
892.5050 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 Safe FDA UDI

Category: Patient positioning thermoplastic mould material

Uni-frame® Thermoplastic by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning thermoplastic mould material.

Cleared under the same submission

K080072 also covers:

K093738 also covers:

K933227 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtec LLC

Sources (2)

  • FDA UDI 914af92b-2776-42ef-9576-e2b86bab964f 37 fields · synced Jul 11, 2026
  • EUDAMED 86ba4910-f0ef-429d-b671-4ee399ec579b 61 fields · synced Jul 11, 2026