FDA UDI Not in Commercial Distribution 🇺🇸 United States

X-OMAT MX Developer and Replenisher

DI: 60889971101617 · Model: X-OMAT MX Developer and Replenisher · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
X-OMAT MX Developer and Replenisher
Primary DI
60889971101617
Version / Model
X-OMAT MX Developer and Replenisher
Catalog Number
1101617
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
3
Public Version Date
2020-06-05
Public Version Status
Update
Public Device Record Key
a976e6af-b42f-4798-b3ae-54d8a3d99085
Distribution End Date
2020-05-25

Device Description

X-OMAT MX Developer and Repl 38L

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
41008 X-ray film processing chemical, manual
41009 X-ray film processing chemical, automatic

Identifiers

Type ID
Primary 60889971101617