AccessGUDID - DEVICE: Voyantmark Assembly (04056481001759)

GUDID

Device Identifier (DI) Information

Brand Name: Voyantmark Assembly
Version or Model: 54243-13
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 54243-13
Company Name: Brainlab AG

Primary DI Number: 04056481001759
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 314482980 *Terms of Use

Device Description: No description.

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?
40806	Radiographic image marker, automatic	A camera or image formatting unit that is a component of a diagnostic imaging system used to imprint identifying marks on: 1) photographic film or x-ray film (by exposure to visible light); or 2) digitally, on images created using various diagnostic imaging modalities [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. Depending on the design of the marking system, it may be electronically or computer-controlled. Most frequently, it is used to imprint information on the images related to image acquisition parameters, patient identification, and to record anatomical information on individual images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAC	System, X-Ray, Film Marking, Radiographic

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: 53554392-4d70-42ad-b984-08cb8021eaa6
Public Version Date: January 31, 2023
Public Version Number: 4
DI Record Publish Date: September 15, 2016