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 FDA UDI
- Primary DI / UDI-DI
- 00853704002470 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
- Not 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
MR Conditional FDA UDI
iStent infinite by Glaukos Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K220032 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Glaukos Corporation
Sources (1)
- FDA UDI 09fc26ad-d4c3-46cb-a195-44e8471c72ca 37 fields · synced Jun 8, 2026