CS 8100
- Primary DI
- 60889975313801
- Brand
- CS 8100
- Company
- CARESTREAM HEALTH, INC.
- Model
- CS 8100
- Catalog number
- 5313804
- Device description
- 3D UPGRADE KIT FOR CS 8100
- Published
- 2016-09-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- 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 |
|---|
| 60889975313801 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 60889975313801 | 60889975313801 |
GMDN Terms
| Term | Definition |
|---|
| Stationary extraoral dental x-ray system, digital | A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. 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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| 60889978818891 | Ultra-speed | Ultra-speed | 8818890 | 2023-06-26 |
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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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