FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRABEAM SMART Spherical Applicator (45mm)
DI: 04049539105578
·
Model: 309120-9045-000
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INTRABEAM SMART Spherical Applicator (45mm)
- Primary DI
- 04049539105578
- Version / Model
- 309120-9045-000
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-14
- Public Version
- 1
- Public Version Date
- 2025-05-22
- Public Version Status
- New
- Public Device Record Key
- d1e8da95-5c25-443c-951f-7e95d9c4f7ab
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | Radiology | 892.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67514 | Intraoperative/postoperative therapeutic x-ray system spherical applicator, single-use | A component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used in the treatment of certain clinical conditions (e.g., breast cancer). It has a ball-shaped distal end that is typically inserted into a resected tumour bed for the irradiation of the tumour bed and/or margins during an operation. It may be supplied as a set of graduated sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539105578 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241174 | 000 |