Westcott Biopsy Needle MWN2208US

GUDID 20886333003123

Westcott Biopsy Needle with Echogenic Tip 22ga x 20cm

ARGON MEDICAL DEVICES, INC.

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• Primary Device ID: 20886333003123
• NIH Device Record Key: 3135bd70-98a3-4385-a99f-a65aea88d657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Westcott Biopsy Needle
• Version Model Number: MWN2208US
• Catalog Number: MWN2208US
• 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
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

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
• 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
• 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	00886333003129 [Primary]
GS1	20886333003123 [Package]; Contains: 00886333003129; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-15
• Device Publish Date: 2021-10-07

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• 20886333003055: Westcott Biopsy Needle 22ga x 9cm
• 20886333003048: Westcott Biopsy Needle 22ga x 15cm
• 20886333003123: Westcott Biopsy Needle with Echogenic Tip 22ga x 20cm