AccessGUDID - DEVICE: RP X-OMAT LO Fixer and Replenisher (60889978239528)

GUDID

Device Identifier (DI) Information

Brand Name: RP X-OMAT LO Fixer and Replenisher
Version or Model: RP X-OMAT LO Fixer and Replenisher
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8239527
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889978239528
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: RP X-OMAT LO FIXER AND REPL PART B 250GL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41009	X-ray film processing chemical, automatic	A chemical, e.g., a fixer or developer, which is necessary for automatic processing of x-ray film or other radiographic films used in, e.g., computed tomography (CT), magnetic resonance (MR), ultrasound or nuclear medicine. This GMDN code will include those chemicals, and in some cases their specialized containers, e.g., prefilled cartridges, designed specifically for use with automatic daylight or darkroom radiographic film processors.	Active	false
41008	X-ray film processing chemical, manual	A chemical, e.g., a fixer or developer, used in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b3dd45c-5aa2-4557-901c-ef75a7283e09
Public Version Date: July 02, 2021
Public Version Number: 3
DI Record Publish Date: September 16, 2016