Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu AS3-002T

GUDID 08175700106689

Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titanium

AURORA SURGICAL, LLC

Ophthalmic angular gauge, reusable
Primary Device ID08175700106689
NIH Device Record Key71a282cf-8b31-4b05-be5c-95c09c9bd4ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameToric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu
Version Model NumberAS3-002T
Catalog NumberAS3-002T
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
GS108175700106689 [Primary]

FDA Product Code

HLFDevice, Measuring, Lens Radius, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


[08175700106689]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

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08175700157537 - Punches2024-07-18 Lewis Lens Loop, Small
08175700157544 - Punches2024-07-18 Lewis Lens Loop, Large

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