LacriCATH

Basic Information

• Brand Name: LacriCATH
• Primary DI: 10634624810201
• Version / Model: LDC508T
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f8ac1e58-75e7-43ef-a81d-6053b55f337a

Device Description

LacriCATH Lacrimal Duct Balloon Catheter 5 mm

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OKS	Lacrimal Stents And Intubation Sets	Unknown		U

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
Primary	10634624810201	GS1
Package	20634624785087	GS1	Shipper	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113867	000