Spatula-Guide for Corneal Endothelium Implantation

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name: Spatula-Guide for Corneal Endothelium Implantation FDA UDI
Generic Name: Ophthalmic surgical probe, reusable FDA UDI
Device Name: Spatula-Guide for Corneal Endothelium Implantation FDA UDI
Model / Reference: AS8-151 FDA UDI
Description: Spatula-Guide for Corneal Endothelium Implantation FDA UDI

Identifiers

Catalog Number: AS8-151 FDA UDI
Primary DI / UDI-DI: 08175700136594 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: Ophthalmic surgical probe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic surgical probe, reusable

Spatula-Guide for Corneal Endothelium Implantation by Aurora Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Aurora Surgical, Llc

Sources (1)

FDA UDI b64c822f-cdfa-4052-9d43-e9ecb4c3d255 34 fields · synced May 31, 2026