LacriCATH

GUDID 20634624438518

LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation device, and one LIS052 STENTube intubation device.

QUEST MEDICAL INC

Lacrimal intubation set

• Primary Device ID: 20634624438518
• NIH Device Record Key: 54871cd8-c5e8-4100-b37e-8b1625769563
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LacriCATH
• Version Model Number: DCR508-UNIT
• Company DUNS: 041810693
• Company Name: QUEST MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20634624438518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113867

FDA Product Code

• OKS: Lacrimal Stents And Intubation Sets

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-05-18

On-Brand Devices [LacriCATH]

• 20634624438525: LacriCATH kit DCR508-BIT contains two lacrimal duct catheters (5 mm), one AQL 1015 inflation dev
• 20634624438518: LacriCATH kit DCR508-UNIT contains one lacrimal duct catheter 5mm, one AQL 1015 inflation device
• 20634624438327: LacriCATH kit DCP315-BIT contains two lacrimal duct catheters (3 mm), one AQL1015 inflation devi
• 20634624438310: LacriCATH DCP315-UNIT contains one lacrimal duct catheter (3mm), and one AQL 1015 Inflation devi
• 20634624438228: LacriCATH Model DCP213-BIT contains two lacrimal duct catheters, one AQL1015 Inflation device, a
• 20634624438211: LacriCATH DCP2mm Unilateral kit. Contains one Lacrimal Duct Catheter and one AQL1015 Inflation