Instylla Microcatheter N/A

GUDID 00812013030048

N/A

Instylla Inc.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

• Primary Device ID: 00812013030048
• NIH Device Record Key: 75d47a43-b77b-435b-bfbf-375a6469dcbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instylla Microcatheter
• Version Model Number: INS90-2001-004
• Catalog Number: N/A
• Company DUNS: 081009360
• Company Name: Instylla 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: false
• 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: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx
• Phone: 781-790-4860
• Email: xx@xx.xx

Device Dimensions

• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter
• Device Size Text, specify: 0
• Length: 122 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812013030048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200744

FDA Product Code

• KRA: Catheter, Continuous Flush

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [Instylla Microcatheter]

• 00812013030062: N/A
• 00812013030055: N/A
• 00812013030048: N/A