AccessGUDID - DEVICE: DRX - Ascend System (60889976574638)

GUDID

Device Identifier (DI) Information

Brand Name: DRX - Ascend System
Version or Model: DRX - Ascend System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6574636
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889976574638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: QG-TV10-C TECHVISION RS-590 WITH Q-VISIO

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?
40847	X-ray system computer, diagnostic, general-purpose	A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMD	System, digital image communications, 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: 3af6eb82-776e-4346-9e80-796133b7eb23
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 14, 2017