Anodyne Surgical

Basic Information

• Brand Name: Anodyne Surgical
• Primary DI: 00840516116891
• Version / Model: 5010
• Company Name: Psi/Eye-Ko, Inc.
• Labeler DUNS: 063763833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-28
• Public Version: 1
• Public Version Date: 2023-09-05
• Public Version Status: New
• Public Device Record Key: 6a5ceec5-425e-4b98-8f5b-1a81fe367712

Device Description

Irrigating Sharp Cystotome [KELMAN] 22g X 25mm (1")

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Radiation Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNY	Cystotome	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46705	Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use	A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840516120768	GS1	Bag	50	In Commercial Distribution
Primary	00840516116891	GS1
Package	00840516124636	GS1	Bag	500	In Commercial Distribution

Customer Contacts

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