AccessGUDID - DEVICE: Remote Control (Onyx) (17630039300767)

GUDID

Device Identifier (DI) Information

Brand Name: Remote Control (Onyx)
Version or Model: 102409
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 102409
Company Name: Bracco Injeneering SA

Primary DI Number: 17630039300767
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 482489007 *Terms of Use

Device Description: EmpowerCTA+ 17" Remote 1721

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?
36968	Contrast medium injection system control unit	A mains electricity (AC-powered) electronic device that may be a component of a contrast medium injector system and designed to initiate and terminate the operation of a contrast medium injection procedure from a remote location (e.g., the shielded operators control room).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSB	Plethysmograph, Impedance
JAK	System, X-Ray, Tomography, Computed
IZQ	Injector, Contrast Medium, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Dry environment

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 678ecfdf-3a03-4d51-8f69-2c6e68496245
Public Version Date: May 08, 2024
Public Version Number: 3
DI Record Publish Date: September 20, 2016