FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRABEAM® Spherical Applicator 2.0 cm
DI: 04049539101570
·
Model: 304534-6000-558
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTRABEAM® Spherical Applicator 2.0 cm
- Primary DI
- 04049539101570
- Version / Model
- 304534-6000-558
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c9278772-cde7-4875-acdc-dd07736f27ad
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 59681 | Intraoperative/postoperative therapeutic x-ray system spherical applicator | A non-sterile 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 with a sterilization tray. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539101570 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121653 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.0 | Centimeter |