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iStent Infinite

FDA UDI

Class II (US FDA UDI)

by Glaukos Corporation

Identity

Trade Name
iStent Infinite FDA UDI
Generic Name
Glaucoma micro-stent FDA UDI
Device Name
Trabecular Micro-Bypass System FDA UDI
Model / Reference
iS3 FDA UDI
Description
Trabecular Micro-Bypass System FDA UDI

Identifiers

Catalog Number
iS3-US FDA UDI
Primary DI / UDI-DI
00853704002449 FDA UDI
510(k) Number
K220032 FDA UDI
FDA Product Code
KYF FDA UDI
GMDN Term
Glaucoma micro-stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.3920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Glaucoma micro-stent

iStent Infinite by Glaukos Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glaucoma micro-stent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Glaukos Corporation

Sources (1)

  • FDA UDI 45c8e88f-dc26-4b81-9cce-590e53b27203 36 fields · synced Jun 8, 2026