FDA UDI
In Commercial Distribution
🇺🇸 United States
SCAN CEPH
DI: 60889975500430
·
Model: SCAN CEPH
·
CARESTREAM HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCAN CEPH
- Primary DI
- 60889975500430
- Version / Model
- SCAN CEPH
- Catalog Number
- 5500434
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 89268c72-136c-4557-8279-bf80b8ae1afa
Device Description
SCAN CEPH UPGRADE FOR CS 8100 3D
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| OAS | X-ray, tomography, computed, dental | Radiology | 892.1750 | 2 |
| MUH | System,x-ray,extraoral source,digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43620 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60889975500430 | GS1 |