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Uni-frame® Thermoplastic

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Uni-frame® Thermoplastic FDA UDI
Generic Name
Patient positioning thermoplastic mould material FDA UDI
Device Name
25.4cm ComfortPerf® thermoplastic (3.2mm) FDA UDI
Model / Reference
MTAPUCP301 FDA UDI
Description
25.4cm ComfortPerf® thermoplastic (3.2mm) FDA UDI

Identifiers

Catalog Number
MTAPUCP301 FDA UDI
Primary DI / UDI-DI
10841439103477 FDA UDI
510(k) Number
K080072 FDA UDI
K093738 FDA UDI
K933227 FDA UDI
FDA Product Code
IYE FDA UDI
LNH FDA UDI
GMDN Term
Patient positioning thermoplastic mould material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

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

Cleared under the same submission

K080072 also covers:

K093738 also covers:

K933227 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 39bab785-09da-45d5-97bb-de46efae6565 38 fields · synced Jun 1, 2026