Identity
- Trade Name
- INTRABEAM SMART Spherical Applicator FDA UDI
- Generic Name
- Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use FDA UDI
- Model / Reference
- 309120-9015-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539105516 FDA UDI
- 510(k) Number
- K241174 FDA UDI
- FDA Product Code
- JAD FDA UDI
- GMDN Term
- Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use
INTRABEAM SMART Spherical Applicator by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use.
- INTRABEAM SMART Spherical Applicator (35mm) — Carl Zeiss Meditec AG · Class II
- INTRABEAM SMART Spherical Applicator (45mm) — Carl Zeiss Meditec AG · Class II
- INTRABEAM SMART Spherical Applicator (35 mm) — Carl Zeiss Meditec AG · Class II
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG · Class II
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG · Class II
Cleared under the same submission
K241174 also covers:
- INTRABEAM — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (35 mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (35mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (40mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Spherical Applicator (45mm) — Carl Zeiss Meditec AG
- INTRABEAM SMART Stand — Carl Zeiss Meditec AG
- INTRABEAM Spherical Sizer Set — Carl Zeiss Meditec AG
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 4c51cdd5-df16-4a8f-850d-978434312ba3 33 fields · synced May 30, 2026