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
MUH System, X-Ray, Extraoral Source, Digital
OAS X-Ray, Tomography, Computed, Dental

GMDN Terms

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

Identifiers

Type ID
Primary 60192155943232