FDA UDI
In Commercial Distribution
🇺🇸 United States
CS 7600 Smart Plate
DI: 40192155942552
·
Model: CS 7600 Smart Plate
·
CARESTREAM DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- CS 7600 Smart Plate
- Primary DI
- 40192155942552
- Version / Model
- CS 7600 Smart Plate
- Catalog Number
- 5942552
- Company Name
- CARESTREAM DENTAL LLC
- Labeler DUNS
- 019796106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-02-17
- Public Version
- 2
- Public Version Date
- 2023-07-04
- Public Version Status
- Update
- Public Device Record Key
- d041b5c7-d6b1-41a7-90ff-f1b7a138dc44
Device Description
CSD SMART PLATE SIZE 3 V2 - 4 PCS
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EAM | Screen, Intensifying, Radiographic | Radiology | 892.1960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44826 | Digital imaging storage phosphor screen | A photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60192155942556 | GS1 | CS | 20 | In Commercial Distribution | |
| Primary | 40192155942552 | GS1 | ||||
| Unit of Use | 00192155942554 | GS1 |