AccessGUDID - DEVICE: IntraX Film Processor (05060209580777)

GUDID

Device Identifier (DI) Information

Brand Name: IntraX Film Processor
Version or Model: MK6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I/MAC2016F
Company Name: MEDIVANCE INSTRUMENTS LIMITED

Primary DI Number: 05060209580777
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 228066353 *Terms of Use

Device Description: No description.

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):	Yes
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?
15939	Dental automated x-ray film processor	A mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXW	Processor, Radiographic-Film, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093503	000

Device Exempt from Premarket Submission: No 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: c54e450a-6147-4c80-95ee-7e11ce987759
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 06, 2022