Instylla Delivery Kit N/A

GUDID 00812013030000

N/A

Instylla Inc.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 00812013030000
• NIH Device Record Key: b38b7135-eb83-4e09-9ad0-30c8d3f4628d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instylla Delivery Kit
• Version Model Number: INS90-3001-002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812013030000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191659

FDA Product Code

• FMF: Syringe, Piston

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

Devices Manufactured by Instylla Inc.

• 00812013030086 - Instylla Microcatheter 1.2: 2021-09-15 N/A
• 00812013030093 - Instylla Microcatheter 1.2: 2021-09-15 N/A
• 00812013030109 - Instylla Microcatheter 1.2: 2021-09-15 N/A
• 00812013030000 - Instylla Delivery Kit: 2020-11-30N/A
• 00812013030000 - Instylla Delivery Kit: 2020-11-30 N/A
• 00812013030048 - Instylla Microcatheter: 2020-11-30 N/A
• 00812013030055 - Instylla Microcatheter: 2020-11-30 N/A
• 00812013030062 - Instylla Microcatheter: 2020-11-30 N/A