AccessGUDID - DEVICE: V-Mark™ Breast Biopsy Site Marker (00886333007141)

GUDID

Device Identifier (DI) Information

Brand Name: V-Mark™ Breast Biopsy Site Marker
Version or Model: 11 ga
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 766411150T
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333007141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: V-Mark Breast Biopsy Site Marker with Titanium Anchor. For Devicor Mammotome 11 ga Probe

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:	Yes
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?
36115	Radiological image marker, ingestible	A device intended to be orally introduced for ingestion to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a capsule used to locate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEU	Marker, Radiographic, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 11 ga

Device Record Status

Public Device Record Key: 807c0bfc-cb7e-4f7c-a431-fb89c1873572
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: October 23, 2015