Disposable Instruments

Basic Information

• Brand Name: Disposable Instruments
• Primary DI: 20845819001459
• Version / Model: B-4002F-NSC
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2023-05-30
• Public Version: 1
• Public Version Date: 2023-06-07
• Public Version Status: New
• Public Device Record Key: b14f82fc-d1f0-4eec-93a0-111cfb9e3b05

Device Description

Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 4mm Bend, Bulk, Non-sterile

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: No
• Sterilization Prior Use: No

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
Primary	20845819001459	GS1
Unit of Use	00845819001455	GS1

Customer Contacts

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