DALK Spatula, Beveled Tip (Bonfadini Style) 1mm Wide, Horizontal Groove On Top<

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name: DALK Spatula, Beveled Tip (Bonfadini Style) 1mm Wide, Horizontal Groove On Top< FDA UDI
Generic Name: Ophthalmic surgical probe, reusable FDA UDI
Device Name: DALK Spatula, Beveled Tip (Bonfadini Style) 1mm Wide, Horizontal Groove On Top< Angled/Vaulted 45 Degree, 8mm from Bend To Tip FDA UDI
Model / Reference: AS8-210S FDA UDI
Description: DALK Spatula, Beveled Tip (Bonfadini Style) 1mm Wide, Horizontal Groove On Top< Angled/Vaulted 45 Degree, 8mm from Bend To Tip FDA UDI

Identifiers

Catalog Number: AS8-210S FDA UDI
Primary DI / UDI-DI: 08175700136891 FDA UDI
FDA Product Code: HNQ 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

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic surgical probe, reusable

DALK Spatula, Beveled Tip (Bonfadini Style) 1mm Wide, Horizontal Groove On Top< by Aurora Surgical, Llc — Class I — FDA UDI — listed in FDA GUDID

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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 a4cdda05-7bbc-441c-b5e5-f6f059300c55 34 fields · synced Jun 8, 2026