TRAB(TM)360 Trabeculotomy System

GUDID 00858027006112

US version of the TRAB360

SIGHT SCIENCES, INC.

Trabeculotome, single-use
Primary Device ID00858027006112
NIH Device Record Key0062e8fc-6537-45d5-ab20-bfb66f724b8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRAB(TM)360 Trabeculotomy System
Version Model NumberFG 03706
Company DUNS962750381
Company NameSIGHT SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858027006112 [Primary]

FDA Product Code

HMZTrabeculotome

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-23

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