FDA UDI In Commercial Distribution 🇺🇸 United States

4343R Digital Image Receptor

DI: 60889974007473 · Model: 4343R Digital Image Receptor · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
4343R Digital Image Receptor
Primary DI
60889974007473
Version / Model
4343R Digital Image Receptor
Catalog Number
9G9998
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
e4298c5c-c663-49d8-9257-473386dbcfc2

Device Description

43X43 GOS DETECTOR

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
MQB Solid state x-ray imager (flat panel/digital imager)

GMDN Terms

Code Name
37645 Stationary basic diagnostic x-ray system, digital

Identifiers

Type ID
Primary 60889974007473