Trabeculotome AS14-205L-T

GUDID 08175700156561

Harms Trabeculotome, Left, Titanium

AURORA SURGICAL, LLC

Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch Corneoscleral punch
Primary Device ID08175700156561
NIH Device Record Key49ea160c-46fa-4459-a902-f7e123f78c39
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrabeculotome
Version Model NumberAS14-205L-T
Catalog NumberAS14-205L-T
Company DUNS968368832
Company NameAURORA SURGICAL, LLC
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108175700156561 [Primary]

FDA Product Code

HNJPunch, Corneo-Scleral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


[08175700156561]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-14
Device Publish Date2024-02-06

On-Brand Devices [Trabeculotome]

08175700156592Mcpherson Trabeculotome, Curved, Angled 8mm Long, Pointed, 3mm Spread, Right
08175700156585Mcpherson Trabeculotome, Curved, Angled 8mm Long, Pointed, 3mm Spread, Left
08175700156578Harms Trabeculotome, Right, Titanium
08175700156561Harms Trabeculotome, Left, Titanium
08175700156554Harms Trabeculotome, Right, Stainless Steel
08175700156547Harms Trabeculotome, Left, Stainless Steel

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.