FDA UDI In Commercial Distribution 🇺🇸 United States

X-OMAT Developer Starter

DI: 60889975239385 · Model: X-OMAT Developer Starter · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
X-OMAT Developer Starter
Primary DI
60889975239385
Version / Model
X-OMAT Developer Starter
Catalog Number
5239389
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-07-26
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
ab9f53d0-c66c-466b-ac2d-eef0bdd2cb5e

Device Description

X-OMAT DEVELOPER STARTER 3L

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
Yes
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
IWZ Film, radiographic

GMDN Terms

Code Name
41009 X-ray film processing chemical, automatic

Identifiers

Type ID
Primary 60889975239385