STENTube Lacrimal Intubation Set

Basic Information

• Brand Name: STENTube Lacrimal Intubation Set
• Primary DI: 10634624815527
• Version / Model: LIS052
• Catalog Number: LIS052
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-07
• Public Version: 5
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 4e83ffab-ce1a-4f46-898d-9f35cb2c6d2d

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
47929	Lacrimal intubation set	A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10634624815527	GS1

Premarket Submissions

Submission Number	Supplement Number
K113118	000