Instylla Microcatheter N/A

GUDID 00812013030055

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	00812013030055
NIH Device Record Key	b817c41e-8e08-4c2e-b32b-52e0744992d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Instylla Microcatheter
Version Model Number	INS90-2001-005
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	142 Centimeter
Length	142 Centimeter
Length	142 Centimeter
Length	142 Centimeter
Length	142 Centimeter
Length	142 Centimeter
Length	142 Centimeter
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter
Device Size Text, specify	0
Length	142 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812013030055 [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