Pterygium Instruments

FDA UDI

Class I (US FDA UDI)

by Aurora Surgical, Llc

Identity

Trade Name: Pterygium Instruments FDA UDI
Generic Name: Burring power tool attachment FDA UDI
Device Name: Round Diamond Burr 3.5mm Diameter (Burr with Chuck Only) FDA UDI
Model / Reference: AS4-103B FDA UDI
Description: Round Diamond Burr 3.5mm Diameter (Burr with Chuck Only) FDA UDI

Identifiers

Catalog Number: AS4-103B FDA UDI
Primary DI / UDI-DI: 08175700115032 FDA UDI
FDA Product Code: GFF FDA UDI
GMDN Term: Burring power tool attachment FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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: Burring power tool attachment

Pterygium Instruments 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 9ce38951-ec32-4e62-8476-69d27e8ecc6d 35 fields · synced Jun 1, 2026