Guidewire 395126

GUDID 10886333210890

Guidewire 18/40/NIT/Mandrel w/Palladium Coil/Straight

ARGON MEDICAL DEVICES, INC.

Peripheral vascular guidewire, manual

• Primary Device ID: 10886333210890
• NIH Device Record Key: 1a952982-1bc5-4f97-8e1a-50b54fd46a38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidewire
• Version Model Number: 395126
• Catalog Number: 395126
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333210893 [Primary]
GS1	10886333210890 [Package]; Contains: 00886333210893; Package: Box [10 Units]; In Commercial Distribution
GS1	20886333210897 [Package]; Contains: 00886333210893; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021990

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2019-02-01
• Device Publish Date: 2016-09-21

On-Brand Devices [Guidewire]

• 10886333221179: Guidewire 25/260/FC/PTFE/1.5J
• 10886333221162: Guidewire 25/150/FC/PTFE/DE-1.5J<
• 10886333216328: Guidewire 32/150/FC/PTFE/1.5J
• 10886333216311: Guidewire 35/150/FC/PTFE/1.5J
• 10886333216304: Guidewire 35/200/FC/PTFE/3J
• 10886333216298: Guidewire 32/125/FC/PTFE/3J
• 10886333216281: Guidewire 32/150/FC/PTFE/3J
• 10886333216274: Guidewire 25/150/FC/PTFE/3J
• 10886333216267: Guidewire 35/180/FC/PTFE/3J
• 10886333216250: Guidewire 35/260/FC/PTFE/ST
• 10886333216243: Guidewire 35/150/Movable Core/PTFE/3J/HD
• 10886333216236: Guidewire 38/150/FC/PTFE/3J
• 10886333216229: Guidewire 35/150/FC/PTFE/3J
• 10886333216212: Guidewire 35/150/FC/PTFE/ST
• 10886333212290: Guidewire 35/50/FC/PTFE/DE/3J&ST
• 10886333212276: Guidewire 35/150/FC/PTFE/3J/HD
• 10886333212269: Guidewire 30/150/FC/PTFE/3J
• 10886333212252: Guidewire 28/50/FC/DE/3J&ST
• 10886333212245: Guidewire 17/150/FC/Mullins
• 10886333212238: Guidewire 15/150/FC/Mullins
• 10886333212221: Guidewire 28/40/FC/ST
• 10886333212214: Guidewire 28/150/FC/PTFE/3J
• 10886333212207: Guidewire 21/100/FC/Mullins/2cm Soft Tip
• 10886333212191: Guidewire 21/65/FC/Mullins/2cm Soft Tip
• 10886333212184: Guidewire 18/100/FC/Mullins/2cm Soft Tip
• 10886333212177: Guidewire 18/65/FC/Mullins/2cm Soft Tip
• 10886333212160: Guidewire 38/150/FC/PTFE/BENTSON
• 10886333212153: Guidewire 32/150/FC/PTFE/BENTSON
• 10886333212146: Guidewire 35/150/FC/PTFE/BENTSON
• 10886333212139: Guidewire 38/80/FC/3J
• 10886333212122: Guidewire 35/150/FC/PTFE/DE/LT&1.5J
• 10886333212115: Guidewire 32/150/FC/PTFE/1.5J
• 10886333212108: Guidewire 35/65/FC/DE/3J&ST
• 10886333212092: Guidewire 28/150/FC/PTFE/ST
• 10886333212085: Guidewire 25/65/FC/ST
• 10886333212078: Guidewire 21/65/FC/PTFE/ST
• 10886333212061: Guidewire 18/65/FC/PTFE/ST
• 10886333212054: Guidewire 35/80/FC/DE/3J&ST
• 10886333212047: Guidewire 38/150/FC/PTFE/1.5J
• 10886333212030: Guidewire 38/50/FC/DE/3J&ST
• 10886333212023: Guidewire 38/70/FC/ST
• 10886333212016: Guidewire 38/260/FC/PTFE/3J
• 10886333212009: Guidewire 38/60/FC/3J
• 10886333211996: Guidewire 38/50/FC/3J
• 10886333211989: Guidewire 38/200/FC/PTFE/3J
• 10886333211972: Guidewire 35/70/FC/3J
• 10886333211965: Guidewire 35/260/FC/PTFE/3J
• 10886333211958: Guidewire 35/150/FC/PTFE/1.5J
• 10886333211941: Guidewire 35/150/FC/PTFE/7.5J
• 10886333211934: Guidewire 35/50/FC/ST