Identity
- Trade Name
- Universal Couchtop™ FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Varian Exact™ Couchtop with Lok-Bar™ FDA UDI
- Model / Reference
- MTIL614115 FDA UDI
- Description
- Varian Exact™ Couchtop with Lok-Bar™ FDA UDI
Identifiers
- Catalog Number
- MTIL614115 FDA UDI
- Primary DI / UDI-DI
- 00841439105641 FDA UDI
- 510(k) Number
- K973842 FDA UDI
- FDA Product Code
- IXQ FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 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
Category: Indexed-immobilization patient positioning system
Universal Couchtop™ by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K973842 also covers:
- Body Pro-Lok™ Bridge — Medtec LLC
- Body Pro-Lok™ Platform — Medtec LLC
- Docking Station — Medtec LLC
- Docking Station — Medtec LLC
- Handle — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- IPPS™ Overlay — Medtec LLC
- Interface for Varian — Medtec LLC
- Interloc® Lok-Bar™ — 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 2414096e-e1c6-4662-964b-fda87c4dbe98 36 fields · synced Jun 6, 2026