Identity
- Trade Name
- NC32 INTRABEAM® Floor Stand FDA UDI
- Generic Name
- Intraoperative/postoperative therapeutic x-ray system FDA UDI
- Model / Reference
- 000000-1096-945 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539101761 FDA UDI
- FDA Product Code
- KMN FDA UDI
- GMDN Term
- Intraoperative/postoperative therapeutic x-ray system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6140 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraoperative/postoperative therapeutic x-ray system
NC32 INTRABEAM® Floor Stand by Carl Zeiss Meditec AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intraoperative/postoperative therapeutic x-ray system.
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- INTRABEAM® Cart — Carl Zeiss Meditec AG · Class I
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI c31136b8-b49e-4db1-b75c-3fe2adb656c4 32 fields · synced May 30, 2026