Hydrus® Microstent F00022

GUDID 20867487000138

Hydrus® Microstent

IVANTIS, INC.

Glaucoma micro-stent

• Primary Device ID: 20867487000138
• NIH Device Record Key: 8b5808c8-2c9a-47fb-b539-d2333aac305b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrus® Microstent
• Version Model Number: F00022
• Catalog Number: F00022
• Company DUNS: 117203550
• Company Name: IVANTIS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com
• Phone: 8664826847
• Email: info@ivantisinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867487000134 [Primary]
GS1	10867487000131 [Package]; Contains: 00867487000134; Package: Box [5 Units]; In Commercial Distribution
GS1	20867487000138 [Package]; Contains: 10867487000131; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170034

FDA Product Code

• OGO: Intraocular Pressure Lowering Implant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-07
• Device Publish Date: 2018-08-15