AccessGUDID - DEVICE: DRX - Ascend System (60889971013859)

GUDID

Device Identifier (DI) Information

Brand Name: DRX - Ascend System
Version or Model: DRX - Ascend System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1013853
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889971013859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: 50 KW/125 KVP QUEST HF SE GEN

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?
37604	Diagnostic x-ray system generator, stationary	A generator which is an integral component of a stationary diagnostic x-ray system, e.g., a system intended to be operated at a fixed location within a facility or mobile imaging van. It is used to regulate incoming voltage and current to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It typically comprises a control assembly (console) and high voltage transformer assembly, or it is of a mono-tank generator design and includes transformer, constant potential, inverter and capacitor discharge generator designs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZO	Generator, high-voltage, x-ray, diagnostic

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: ea71a0b4-315e-49fe-af5b-0ac407a50326
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 23, 2016