BioPince™ Full Core Biopsy Instrument 360-1080-01

GUDID 20886333004373

BioPince™ Full Core Biopsy Instrument 18Gx10cm

ARGON MEDICAL DEVICES, INC.

End-cut biopsy gun handpiece/needle End-cut biopsy gun handpiece/needle

• Primary Device ID: 20886333004373
• NIH Device Record Key: 450a262f-dd83-442e-b76f-4e3f3a337a3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPince™ Full Core Biopsy Instrument
• Version Model Number: 360-1080-01
• Catalog Number: 360-1080-01
• 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: true
• 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

Customer Support Contacts

• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333004379 [Primary]
GS1	20886333004373 [Package]; Contains: 00886333004379; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904987

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-01

On-Brand Devices [BioPince™ Full Core Biopsy Instrument]

• 20886333004380: BioPince™ Full Core Biopsy Instrument 16G x 10cm
• 20886333004373: BioPince™ Full Core Biopsy Instrument 18Gx10cm
• 20886333004366: BioPince™ Full Core Biopsy Instrument 16G x 15cm
• 20886333004342: BioPince™ Full Core Biopsy Instrument 18G x 20cm