Identity
- Trade Name
- C-Qual FDA UDI
- Generic Name
- Radiological breast positioner, non-wearable FDA UDI
- Device Name
- Replacement support base FDA UDI
- Model / Reference
- MT40013 FDA UDI
- Description
- Replacement support base FDA UDI
Identifiers
- Catalog Number
- MT40013 FDA UDI
- Primary DI / UDI-DI
- 00841439102688 FDA UDI
- 510(k) Number
- K974703 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological breast positioner, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.4 Centimeter FDA UDILength — 7.6 Centimeter FDA UDI
C-Qual by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K974703 also covers:
- Arm Support — Medtec LLC
- Arm Support — Medtec LLC
- Breastboard — Medtec LLC
- C-Qual M™ — Medtec LLC
- C-Qual™ — Medtec LLC
- C-Qual™ — Medtec LLC
- C-Qual™ — Medtec LLC
- Hip Stop — Medtec LLC
- Hip Stop — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Monarch™ Overhead Arm Positioner — Medtec LLC
- Monarch™ 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 (1)
- FDA UDI e44847d4-8b2a-4583-a30d-9478a3caf1ab 39 fields · synced Jun 8, 2026