CEPHALOSTAT
- Primary DI
- 60889975211015
- Brand
- CEPHALOSTAT
- Company
- CARESTREAM HEALTH, INC.
- Model
- CEPHALOSTAT
- Catalog number
- 5211016
- Device description
- CEPH UPGRADE FOR 9X00 FAMILY
- Published
- 2016-09-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MUH | System,x-ray,extraoral source,digital |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 60889975211015 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 60889975211015 | 60889975211015 |
GMDN Terms
| Term | Definition |
|---|
| Stationary cephalometric x-ray system, digital | A stationary cephalometric x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient's head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull; 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton; 3) assessment airway and other soft tissue structures. The sensor is placed outside the head. The data is either from analogue imaging and digitized afterwards or by digital imaging. |
Regulatory Flags
- DUNS number
- 793169512
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 60889975950549 | DRX Plus 3543C Detector | DRX Plus 3543C Detector | AL6755 | 2021-09-04 |
| 60889975950556 | DRX Plus 4343 DETECTOR | DRX Plus 4343 DETECTOR | AL6759 | 2021-09-04 |
| 60889975950563 | DRX Plus 4343C DETECTOR | DRX Plus 4343C DETECTOR | AL6764 | 2021-09-04 |
| 60889975950570 | Lux 35 Detector | Lux 35 Detector | AK7294 | 2021-08-30 |
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