FDA UDI
In Commercial Distribution
🇺🇸 United States
CS 3500 3D Scanner Collar
DI: 60889976567876
·
Model: CS 3500 3D Scanner Collar
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- CS 3500 3D Scanner Collar
- Primary DI
- 60889976567876
- Version / Model
- CS 3500 3D Scanner Collar
- Catalog Number
- 6567879
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 309a0753-b09f-4776-8125-21026894c1b4
Device Description
CS3500 COLLAR PACKING (10 PIECES)
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 |
|---|---|---|---|---|
| NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | Dental | 872.3661 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38597 | Dental milling system, CAD/CAM, chairside | An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889976567876 | GS1 | ||||
| Unit of Use | 00889976567874 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius