MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle MMCI2203US

GUDID 20886333002874

MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle

ARGON MEDICAL DEVICES, INC.

Soft-tissue biopsy needle, single-use

• Primary Device ID: 20886333002874
• NIH Device Record Key: 17a7d0ba-1b5a-4c71-8776-39df5c970980
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle
• Version Model Number: MMCI2203US
• Catalog Number: MMCI2203US
• 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	00886333002870 [Primary]
GS1	20886333002874 [Package]; Contains: 00886333002870; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980122

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle]

• 20886333002874: MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle
• 20886333002867: MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle