AccessGUDID - DEVICE: Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit (08809466040030)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit
Version or Model: CA02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Digiray Corp.

Primary DI Number: 08809466040030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557815751 *Terms of Use

Device Description: The Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.

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":	Yes
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?
35437	X-ray film cassette, manual	A device used in medical imaging applications to shield x-ray film from exposure to room light during transport and insertion into a diagnostic imaging system, film formatter, or film processor. It is typically designed for use with a particular imaging system or image formatting unit and consists of a plastic or metal housing with removable metal or plastic inserts. Some film cassettes used in x-ray applications can incorporate an x-ray grid into the cassette design.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

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
Width: 30 Centimeter
Length: 24 Centimeter
Weight: 1.5 Kilogram

Device Record Status

Public Device Record Key: eda460d2-7b1b-4ec9-bafc-7eda3956e6be
Public Version Date: February 07, 2020
Public Version Number: 5
DI Record Publish Date: August 02, 2016