FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRABEAM® 600
DI: 04049539064059
·
Model: 6405
·
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® 600
- Primary DI
- 04049539064059
- Version / Model
- 6405
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-11
- Public Version
- 4
- Public Version Date
- 2018-08-14
- Public Version Status
- Update
- Public Device Record Key
- 3d205247-4a12-44e4-a819-3b8d4eb9d4b9
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 59677 | Intraoperative/postoperative therapeutic x-ray system | A mobile (on wheels) assembly of mains electricity (AC-powered) devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of cancer (e.g., breast, brain, skin) typically during or after an operation for tumour resection. It uses a miniature electronic X-ray source (50kV maximum) attached to one of various types and sizes of applicators specific to the clinical application (e.g., from within a resected breast tumour site). It typically consists of an x-ray source and an applicator mounted on a floor stand, verification tools, control unit, and user interface. It may be used in an operating room (OR) or other clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539064059 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162568 | 000 |