Bi-Manual Irrigation/Aspiration

Basic Information

• Brand Name: Bi-Manual Irrigation/Aspiration
• Primary DI: 08175700140508
• Version / Model: AS10-020
• Catalog Number: AS10-020
• Company Name: AURORA SURGICAL, LLC
• Labeler DUNS: 968368832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: e1867fb4-7482-4c5d-afd9-e8ef4ee5400a

Device Description

Irrigation Handpiece For Bimanual Technique, Curved, 21g, Two Ports on Side .35mm

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMX	Cannula, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63231	Ophthalmic surgical irrigation/infusion/aspiration handle, reusable	A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08175700140508	GS1