Visitec®

Basic Information

• Brand Name: Visitec®
• Primary DI: 30886158101247
• Version / Model: 585013
• Catalog Number: 585013
• Company Name: Beaver-Visitec International, Inc.
• Labeler DUNS: 001406024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2021-11-01
• Public Version: 2
• Public Version Date: 2021-11-12
• Public Version Status: Update
• Public Device Record Key: d1d85fe5-a111-4af3-a1b5-e9728cb2900c

Device Description

Lacrimal Intubation with Retrieval Device .60mm x 11cm (23G x 4 1/4in) 3

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
HNL	Probe, Lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63399	Lacrimal tube insertion hook/pusher	A hand-held manual instrument intended for introducing a lacrimal tube/stent into the canaliculi, nasolacrimal duct, and/or nasal cavity through the corner of the eye, during a lacrimal intubation procedure for treating pathologies of the tear drainage system. It may be in the form of a cylinder for pushing the lacrimal tube downwards into the nasal cavity [post-osteotomy during canalicular bypass surgery, dacryocystorhinostomy (DCR)], or a pigtail hook probe that is inserted into the canaliculi through one lacrimal duct punctum and rotated for retrieval via the other punctum, leaving the attached lacrimal tube to be inserted in the canaliculi. This is a reusable device.	No	Active
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
Unit of Use	00886158101246	GS1
Primary	30886158101247	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K831901	000