FDA UDI In Commercial Distribution 🇺🇸 United States

SCAN CEPH

DI: 60192155942396 · Model: SCAN CEPH · CARESTREAM DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SCAN CEPH
Primary DI
60192155942396
Version / Model
SCAN CEPH
Catalog Number
5942396
Company Name
CARESTREAM DENTAL LLC
Labeler DUNS
019796106
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-17
Public Version
2
Public Version Date
2020-06-19
Public Version Status
Update
Public Device Record Key
b490fddd-55b9-458b-893a-b9ab1eaa7be6

Device Description

SCAN CEPH FOR CS 9600

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
OAS X-Ray, Tomography, Computed, Dental

GMDN Terms

Code Name
61019 Cone beam computed tomography system, head/neck

Identifiers

Type ID
Primary 60192155942396