Anodyne Surgical

Basic Information

• Brand Name: Anodyne Surgical
• Primary DI: 00840516131337
• Version / Model: CN2001
• Company Name: Psi/Eye-Ko, Inc.
• Labeler DUNS: 063763833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-21
• Public Version: 2
• Public Version Date: 2023-12-06
• Public Version Status: Update
• Public Device Record Key: 088847a5-a1e6-47ab-a1d4-1494ce68716c

Device Description

Castroviejo Lachrymal Dilator DBL Ended Size 1&2, Round Handle, 120mm Length, SS

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: Yes
• Has Lot/Batch Number: No
• 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
HNW	Dilator, Lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35010	Lacrimal dilator, reusable	A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840516131337	GS1

Customer Contacts

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