VoyantMark

Basic Information

• Brand Name: VoyantMark
• Primary DI: 04056481141394
• Version / Model: 54243-13A
• Catalog Number: 54243-13A
• Company Name: Brainlab AG
• Labeler DUNS: 314482980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-21
• Public Version: 2
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 74097985-062f-44d4-8708-e68df11a9780

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	892.1640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056481141394	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]