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iStent

FDA UDI

Class III (US FDA UDI)

by Glaukos Corporation

Identity

Trade Name
iStent FDA UDI
Generic Name
Glaucoma micro-stent FDA UDI
Device Name
Trabecular Micro-bypass stent system - Left FDA UDI
Model / Reference
GTS100L FDA UDI
Description
Trabecular Micro-bypass stent system - Left FDA UDI

Identifiers

Catalog Number
GTS100L FDA UDI
Primary DI / UDI-DI
00853704002012 FDA UDI
FDA Product Code
OGO FDA UDI
GMDN Term
Glaucoma micro-stent FDA UDI

Classification

Device Class
Class III 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 by Glaukos Corporation — Class III — 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 764a1b82-b9a0-44ed-a94b-047e5d1c8a30 35 fields · synced Jun 8, 2026