Identity
- Trade Name
- Bolus FDA UDI
- Generic Name
- Radiation therapy bolus, reusable FDA UDI
- Device Name
- 30 x 30 x 2.0cm FDA UDI
- Model / Reference
- MTCB420S FDA UDI
- Description
- 30 x 30 x 2.0cm FDA UDI
Identifiers
- Catalog Number
- MTCB420S FDA UDI
- Primary DI / UDI-DI
- 00841439104002 FDA UDI
- FDA Product Code
- IXG FDA UDI
- GMDN Term
- Radiation therapy bolus, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1950 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 30 Centimeter FDA UDILength — 30 Centimeter FDA UDI
Bolus by Medtec LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (1)
- FDA UDI 033a2806-f7f9-440a-a801-4ced758368e8 38 fields · synced Jun 8, 2026