← Back to catalogue

OMNI Surgical System

FDA UDI

Class II (US FDA UDI)

by Sight Sciences, Inc.

Identity

Trade Name
OMNI Surgical System FDA UDI
Generic Name
Ophthalmic needle, single-use FDA UDI
Device Name
OMNI Surgical System, 21 uL FDA UDI
Model / Reference
FG 07758 FDA UDI
Description
OMNI Surgical System, 21 uL FDA UDI

Identifiers

Catalog Number
1-106 FDA UDI
Primary DI / UDI-DI
00858027006433 FDA UDI
510(k) Number
K232214 FDA UDI
FDA Product Code
MRH FDA UDI
HMZ FDA UDI
GMDN Term
Ophthalmic needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
886.4350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic needle, single-useTrabeculotome, single-use

OMNI Surgical System by Sight Sciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trabeculotome, single-use.

Cleared under the same submission

K232214 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sight Sciences, Inc.

Sources (1)

  • FDA UDI c2bb3d8e-fded-453a-a997-d3b5e32cbaa4 35 fields · synced Jun 9, 2026