BioPince Ultra Full Core Biopsy Instrument 360-1080-03

GUDID 20886333224016

BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 18ga x 10cm)(Introducer Needle: 17ga x 6.8cm)

ARGON MEDICAL DEVICES, INC.

End-cut biopsy gun handpiece/needle

• Primary Device ID: 20886333224016
• NIH Device Record Key: dc462ba9-052b-4e84-b4f2-bfbbbc969965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPince Ultra Full Core Biopsy Instrument
• Version Model Number: 360-1080-03
• Catalog Number: 360-1080-03
• 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
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333224012 [Primary]
GS1	20886333224016 [Package]; Contains: 00886333224012; 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: 2
• Public Version Date: 2019-07-12
• Device Publish Date: 2019-04-16

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

• 20886333224054: BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument
• 20886333224047: BioPince™ Ultra Full Core Biopsy Instrument 18ga x 20cm (use with optional Co-Axial Needle: MC
• 20886333224030: BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument
• 20886333224023: BioPince™ Ultra Full Core Biopsy Instrument 18ga x 15cm (use with optional Co-Axial Needle: MC
• 20886333224016: BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrumen
• 20886333224009: BioPince™ Ultra Full Core Biopsy Instrument 18ga x 10cm (use with optional Co-Axial Needle: MC