X-OMAT Developer Starter
- Primary DI
- 60889975239385
- Brand
- X-OMAT Developer Starter
- Company
- CARESTREAM HEALTH, INC.
- Model
- X-OMAT Developer Starter
- Catalog number
- 5239389
- Device description
- X-OMAT DEVELOPER STARTER 3L
- Published
- 2017-07-26
- 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 |
|---|
| IWZ | Film, radiographic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IWZ | Film, Radiographic | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 60889975239385 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 60889975239385 | 60889975239385 |
GMDN Terms
| Term | Definition |
|---|
| X-ray film processing chemical, automatic | A chemical, e.g., a fixer or developer, which is necessary for automatic processing of x-ray film or other radiographic films used in, e.g., computed tomography (CT), magnetic resonance (MR), ultrasound or nuclear medicine. This GMDN code will include those chemicals, and in some cases their specialized containers, e.g., prefilled cartridges, designed specifically for use with automatic daylight or darkroom radiographic film processors. |
Regulatory Flags
- DUNS number
- 793169512
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- 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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|---|
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| 60889976579343 | Vita Flex CR System | Vita Flex CR System | 6579346 | 2019-08-03 |
| 60889976579367 | Vita Flex CR System | Vita Flex CR System | 6579361 | 2019-08-03 |
| 60889978625925 | Carestream DRX-1 System | Carestream DRX-1 System | 8625923 | 2023-07-21 |
| 60889978624768 | DRX-Compass X-ray System | DRX-Compass X-ray System | 8624769 | 2023-06-28 |
| 00889978626487 | D-Speed | D-Speed | 8626483 | 2023-06-26 |
| 60889978818891 | Ultra-speed | Ultra-speed | 8818890 | 2023-06-26 |
| 60889976554104 | CARESTREAM DR Long Length Imaging Stand | CARESTREAM DR Long Length Imaging Stand | 6554109 | 2023-06-26 |
| 60889975950600 | Focus HD 35 Detector | Focus HD 35 Detector | AL4712 | 2023-06-24 |
| 60889975950617 | Focus HD 43 Detector | Focus HD 43 Detector | AL4713 | 2023-06-24 |
| 60889978626007 | DRX-Rise Mobile X-ray System | DRX-Rise Mobile X-ray System | 8626004 | 2023-06-22 |
| 60889976701171 | CARESTREAM Image Suite | CARESTREAM Image Suite | 6701171 | 2022-02-25 |
| 60889971051264 | D-Speed | D-Speed | 1051267 | 2022-01-11 |
| 60889978624188 | DRX-Compass X-ray System | DRX-Compass X-ray System | 8624181 | 2022-01-11 |
| 60889978624195 | DRX-Compass X-ray System | DRX-Compass X-ray System | 8624199 | 2022-01-11 |
| 60889975950532 | DRX Plus 3543 Detector | DRX Plus 3543 Detector | AL6750 | 2021-09-04 |
| 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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