FDA UDI Not in Commercial Distribution 🇺🇸 United States

X-OMAT MX Fixer and Replenisher

DI: 60889971266378 · Model: X-OMAT MX Fixer and Replenisher · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
X-OMAT MX Fixer and Replenisher
Primary DI
60889971266378
Version / Model
X-OMAT MX Fixer and Replenisher
Catalog Number
1266378
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
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
250a616b-8949-4ffe-bb0d-1a49c18e3b31
Distribution End Date
2020-06-04

Device Description

X-OMAT MX FIXER 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
41009 X-ray film processing chemical, automatic
41008 X-ray film processing chemical, manual

Identifiers

Type ID
Primary 60889971266378