FDA UDI
In Commercial Distribution
🇺🇸 United States
SCAN CEPH
DI: 60192155943232
·
Model: 5943238
·
CARESTREAM DENTAL LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCAN CEPH
- Primary DI
- 60192155943232
- Version / Model
- 5943238
- Catalog Number
- 5943238
- Company Name
- CARESTREAM DENTAL LLC
- Labeler DUNS
- 019796106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-22
- Public Version
- 1
- Public Version Date
- 2020-06-30
- Public Version Status
- New
- Public Device Record Key
- b85f1358-e1cf-49eb-bf04-cac91760dfb2
Device Description
SCAN CEPH FOR CS 8200 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
- Yes
- 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 |
|---|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 872.1800 | 2 |
| OAS | X-Ray, Tomography, Computed, Dental | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61019 | Cone beam computed tomography system, head/neck | A stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60192155943232 | GS1 |