FDA UDI In Commercial Distribution 🇺🇸 United States

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

DI: 08175700106689 · Model: AS3-002T · AURORA SURGICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu
Primary DI
08175700106689
Version / Model
AS3-002T
Catalog Number
AS3-002T
Company Name
AURORA SURGICAL, LLC
Labeler DUNS
968368832
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-14
Public Version
1
Public Version Date
2022-11-22
Public Version Status
New
Public Device Record Key
71a282cf-8b31-4b05-be5c-95c09c9bd4ef

Device Description

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

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HLF Device, Measuring, Lens Radius, Ophthalmic

GMDN Terms

Code Name
63521 Ophthalmic angular gauge, reusable

Identifiers

Type ID
Primary 08175700106689