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 Imaging lesion localization marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image marker, ingestible Radiological image 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