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Thermoplastic Frame
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MTPLHA01Model Thermoplastic Devices
by Medtec LLC
Identity
- Trade Name
- Thermoplastic Frame FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Thermoplastic frame set for use with HipFix® FDA UDI
- Model / Reference
- MTPLHA01 EUDAMEDFDA UDIThermoplastic Devices EUDAMED
- Description
- Thermoplastic frame set for use with HipFix® FDA UDI
Identifiers
- Catalog Number
- MTPLHA01 FDA UDI
- Primary DI / UDI-DI
- 00841439107010 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0003R01AA EUDAMED
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 55.9 Centimeter FDA UDIWidth — 2.5 Centimeter FDA UDI
Category: Patient positioning thermoplastic mould material
Thermoplastic Frame by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Patient positioning thermoplastic mould material.
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- Aquaplast RT™ — Qfix · Class II
- Fibreplast® Variable Perf ™ Assure™ Open View — Qfix · Class II
- Aquaplast RT™ — Qfix · Class II
Cleared under the same submission
K080072 also covers:
- Elekta Unity Lok-Bar™ — Medtec LLC
- Elekta Unity QA Lok-Bar™ — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- Slide Guide 3-Pin Lok-Bar™ — Medtec LLC
- Thermoplastic Frame — Medtec LLC
- Type-S™ Thermoplastic — Medtec LLC
- Type-S™ Thermoplastic — Medtec LLC
K093738 also covers:
- AccuForm™ Cushion — Medtec LLC
- Headrest - TIMO Size A, B, C, F — Medtec LLC
- Headrest - Timo size F with base — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posicast® Thermoplastic — Medtec LLC
- Posifix® Headrest — Medtec LLC
K933227 also covers:
- Fixator™ — Medtec LLC
- Fixator™ Shoulder Cups — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- Headrest — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- HipFix® Thermoplastic — Medtec LLC
- MR Posi-S™ Adapter with Backplate — Medtec LLC
- Prone Face Cushion — Medtec LLC
- Shim — Medtec LLC
- Shim — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI a164af8c-3fe8-47f7-a68b-0fce95019a9c 38 fields · synced Jul 9, 2026
- EUDAMED 5ed70c4f-2adb-4962-ae87-11b9996d2d0f 61 fields · synced Jul 9, 2026