Instylla Microcatheter 1.2 N/A

GUDID 00812013030086

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

• Primary Device ID: 00812013030086
• NIH Device Record Key: db26fa55-f1e3-4655-b348-15281ad8507c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instylla Microcatheter 1.2
• Version Model Number: INS90-2001-007
• 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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812013030086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210808

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: 2021-09-15
• Device Publish Date: 2021-09-07

On-Brand Devices [Instylla Microcatheter 1.2]

• 00812013030109: N/A
• 00812013030093: N/A
• 00812013030086: N/A