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Marker

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name
Marker FDA UDI
Generic Name
Ophthalmic angular gauge, reusable FDA UDI
Device Name
Nujits/Solomon Toric IOL Axis Marker w/5.0mm Optical Zone, For Use with Gimble Mendez Beveled Degree Gauge, Stainless Steel FDA UDI
Model / Reference
AS3-003S FDA UDI
Description
Nujits/Solomon Toric IOL Axis Marker w/5.0mm Optical Zone, For Use with Gimble Mendez Beveled Degree Gauge, Stainless Steel FDA UDI

Identifiers

Catalog Number
AS3-003S FDA UDI
Primary DI / UDI-DI
08175700106764 FDA UDI
FDA Product Code
HLF FDA UDI
GMDN Term
Ophthalmic angular gauge, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1430 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic angular gauge, reusable

Marker by Aurora Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic angular gauge, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aurora Surgical, Llc

Sources (1)

  • FDA UDI 31cb5028-554f-4d1a-a6da-8f94de268d0d 35 fields · synced May 30, 2026