BARRAQUER LID SPECULUM 24B

Basic Information

• Brand Name: BARRAQUER LID SPECULUM 24B
• Primary DI: 04058935005245
• Version / Model: SUH01
• Catalog Number: SUH01
• Company Name: Bausch & Lomb GmbH
• Labeler DUNS: 344609518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 2
• Public Version Date: 2024-07-17
• Public Version Status: Update
• Public Device Record Key: c6d5f5aa-a4e0-49f9-af57-a4ee1015d603

Device Description

Single Use Medical Device for Ophthalmic Surgery

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNC	Specula, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46959	Eyelid speculum, single-use	A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	24058935005249	GS1
Primary	04058935005245	GS1