Identity
- Trade Name
- Overlay FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Couchtop EUDAMEDwith Lok-Bar™ for use with Canon Vantage Galan 3T FDA UDI
- Model / Reference
- MTM6506 EUDAMEDFDA UDI
- Description
- with Lok-Bar™ for use with Canon Vantage Galan 3T FDA UDI
Identifiers
- Catalog Number
- MTM6506 FDA UDI
- Primary DI / UDI-DI
- 00841439111796 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0007R01B6 EUDAMED
- 510(k) Number
- K080072 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 2011 Millimeter FDA UDIWidth — 609 Millimeter FDA UDI
Overlay by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- IPPS™ Overlay — Medtec LLC
- Slide Guide 3-Pin Lok-Bar™ — Medtec LLC
- Thermoplastic Frame — Medtec LLC
- Thermoplastic Frame — 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 (2)
- FDA UDI 4b434e73-371c-4d30-b401-1daf5e503008 37 fields · synced Oct 6, 2026
- EUDAMED 503a83e4-5ae3-414d-9a16-2898911e0f29 61 fields · synced Jul 26, 2026