AccessGUDID - DEVICE: DMC-EZ (00850018049030)

GUDID

Device Identifier (DI) Information

Brand Name: DMC-EZ
Version or Model: DMC-EZ 3600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DMC-EZ 3600
Company Name: Storage Solutions Technology Group Inc.

Primary DI Number: 00850018049030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194045303 *Terms of Use

Device Description: DICOM Media Creator - 3600 Thermal

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?
64454	DICOM image data disc-recording unit	A desktop unit intended to interface with an off-the-shelf computer (not included) to collect digital imaging and communications in medicine (DICOM) image data and record (burn) it onto a compact disc (CD) and/or digital video disc (DVD); it may in addition include a disc-label printer. It includes the appropriate software; it does not have any image processing or analysis capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMB	Device, Digital Image Storage, Radiological

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: 205a2238-e5b3-497a-8e0b-8549cd973743
Public Version Date: February 19, 2021
Public Version Number: 1
DI Record Publish Date: February 11, 2021