Bausch + Lomb

FDA UDI

Class I (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name: Bausch + Lomb FDA UDI
Generic Name: Eye muscle hook, reusable FDA UDI
Device Name: CHOPPER RIGHT NAGAHARA FDA UDI
Model / Reference: ET0578 R FDA UDI
Description: CHOPPER RIGHT NAGAHARA FDA UDI

Identifiers

Catalog Number: ET0578 R FDA UDI
Primary DI / UDI-DI: 00757770455096 FDA UDI
FDA Product Code: HNQ FDA UDI
GMDN Term: Eye muscle hook, 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Eye muscle hook, reusable

Bausch + Lomb by Bausch & Lomb Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Scobee Oblique Muscle Hook, 4.5mm — AURORA SURGICAL, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I

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: Bausch & Lomb Incorporated

Sources (1)

FDA UDI 7a3a5cd2-dea5-4631-b4e8-28ef07f6b3a9 34 fields · synced Jun 6, 2026