Identity
- Trade Name
- IPPS™ Overlay FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- For use with Posifix® thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida FDA UDI
- Model / Reference
- MTM3003 FDA UDI
- Description
- For use with Posifix® thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR Aera, Avanto fit, Prisma, Prisma fit, Skyra, Skyra fit, Spectra and Vida FDA UDI
Identifiers
- Catalog Number
- MTM3003 FDA UDI
- Primary DI / UDI-DI
- 00841439106624 FDA UDI
- 510(k) Number
- K080072 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Indexed-immobilization patient positioning system
IPPS™ Overlay by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Indexed-immobilization patient positioning system.
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- KLARITY MEDICAL — Klarity Medical Products, LLC · 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
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI 3dbc7c72-ae21-4ce8-add5-a9916ca3ed19 36 fields · synced Jun 1, 2026