Identity
- Trade Name
- Couchtop Panel FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Reusable non-sterile solid couchtop panel for use with Siemens ZXT or Z4 systems FDA UDI
- Model / Reference
- MTZXTZ44069CS FDA UDI
- Description
- Reusable non-sterile solid couchtop panel for use with Siemens ZXT or Z4 systems FDA UDI
Identifiers
- Catalog Number
- MTZXTZ44069CS FDA UDI
- Primary DI / UDI-DI
- 00841439108932 FDA UDI
- 510(k) Number
- K950068 FDA UDI
- FDA Product Code
- KXJ 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
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 79.4 Centimeter FDA UDIWidth — 49.1 Centimeter FDA UDI
Couchtop Panel by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI ac453935-62de-4310-be4a-24b69ded63d0 39 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026