FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRABEAM
DI: 04049539064080
·
Model: 700
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTRABEAM
- Primary DI
- 04049539064080
- Version / Model
- 700
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-01
- Public Version
- 1
- Public Version Date
- 2025-04-09
- Public Version Status
- New
- Public Device Record Key
- 66a2af8b-6b5b-497b-a97f-d6f29dde1af8
Device Description
The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment. It is intended to deliver, monitor, and report a radiation therapy treatment.
Device Characteristics
- Single Use
- No
- 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
- 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 | 04049539064080 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241174 | 000 |