Lacrimal dilator, single-use

Basic Information

• Brand Name: Lacrimal dilator, single-use
• Primary DI: 03760087120554
• Version / Model: DISPOSABLE PUNCTUM DILATOR AND PLUG INSERTER
• Catalog Number: S1.3090U
• Company Name: FCI S A S FCI 20 22
• Labeler DUNS: 763408366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-02-25
• Public Version: 1
• Public Version Date: 2020-03-04
• Public Version Status: New
• Public Device Record Key: 33976bc1-c3d1-4b0a-8cc6-d42f6a352e8f

Device Description

A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HNW	Dilator, Lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34035	Lacrimal dilator, single-use	A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	33760087120555	GS1
Primary	03760087120554	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	133	Millimeter