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Sion Surgical Instrument

FDA UDI

Class I (US FDA UDI)

by Sight Sciences, Inc.

Identity

Trade Name
Sion Surgical Instrument FDA UDI
Generic Name
Trabeculotome, single-use FDA UDI
Device Name
The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument. FDA UDI
Model / Reference
FG 08255 FDA UDI
Description
The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument. FDA UDI

Identifiers

Catalog Number
1-107 FDA UDI
Primary DI / UDI-DI
00858027006501 FDA UDI
FDA Product Code
HMZ FDA UDI
GMDN Term
Trabeculotome, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Trabeculotome, single-use

Sion Surgical Instrument by Sight Sciences, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trabeculotome, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sight Sciences, Inc.

Sources (1)

  • FDA UDI d6cb0d0c-d3e6-4984-b50c-a0f379bee993 34 fields · synced Jun 9, 2026