V-Mark™ Breast Biopsy Site Marker 766712120SST

GUDID 20886333007169

V-Mark Breast Biopsy Site Marker with Titanium Achor For 12 ga Suros Vacuum Assisted Biopsy System

ARGON MEDICAL DEVICES, INC.

Imaging lesion localization marker, ingestible

• Primary Device ID: 20886333007169
• NIH Device Record Key: cb6e2f27-87c6-466d-a50f-745b46d0bd7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Mark™ Breast Biopsy Site Marker
• Version Model Number: 12 ga
• Catalog Number: 766712120SST
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333007165 [Primary]
GS1	20886333007169 [Package]; Contains: 00886333007165; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053518

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-23

On-Brand Devices [V-Mark™ Breast Biopsy Site Marker ]

• 20886333007183: V-Mark Breast Biopsy Site Marker with Titanium Anchor For Ultrasound Guidance (15 ga x 10.8 cm)
• 00886333007172: V-Mark Breast Biopsy Site Marker with Titanium Anchor For Ultrasound Guidance (15 ga x 18.8 cm)
• 20886333007169: V-Mark Breast Biopsy Site Marker with Titanium Achor For 12 ga Suros Vacuum Assisted Biopsy Syst
• 20886333007152: V-Mark Breast Biopsy Site Marker with Titanium Anchor For 9 ga Suros Vacuum Assisted Biopsy Syst
• 20886333007145: V-Mark Breast Biopsy Site Marker with Titanium Anchor. For Devicor Mammotome 11 ga Probe