FDA UDI In Commercial Distribution 🇺🇸 United States

Trophy Imaging 8

DI: 60192155500688 · Model: Trophy Imaging 8 · CARESTREAM DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Trophy Imaging 8
Primary DI
60192155500688
Version / Model
Trophy Imaging 8
Catalog Number
5500681
Company Name
CARESTREAM DENTAL LLC
Labeler DUNS
019796106
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-05-10
Public Version
3
Public Version Date
2022-03-28
Public Version Status
Update
Public Device Record Key
dda10d27-2a44-41a0-81ba-6d538b1f7cf4

Device Description

Trophy Imaging 8

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
40876 General-purpose dental x-ray system application software

Identifiers

Type ID
Primary 60192155500688