Disposable Instruments

Basic Information

• Brand Name: Disposable Instruments
• Primary DI: 00845819000632
• Version / Model: 4002H, B-4002H
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 68674957-528c-4cdd-9484-5b0f48bc33b0

Device Description

Viscoelastic Cannula, 27g x 7/8" (0.4 x 22mm), 8mm Bend

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: 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
47007	Ophthalmic surgical irrigation/infusion/aspiration handle, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10845819000639	GS1	Carton	10	In Commercial Distribution
Primary	00845819000632	GS1
Package	20845819000636	GS1	Plastic Bag	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]