EAGLE VISION MONOSTENT-P

Basic Information

• Brand Name: EAGLE VISION MONOSTENT-P
• Primary DI: 00844505010023
• Version / Model: 1084
• Company Name: EAGLE VISION, INC.
• Labeler DUNS: 174318360
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 3
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 0550116d-6a51-4a11-ac58-cb04eba696d8
• Distribution End Date: 2017-03-31

Device Description

MONOSTENT - MONOCANALICULAR STENT-P, TUBING:50MM X 0.64MM OD, SILICONE

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
10575	Lacrimal procedural cannula	A hand-held, manual, rigid or semi-rigid instrument intended to be inserted into the lacrimal drainage system (the lacrimal duct) to perform various ocular irrigation or aspiration procedures (e.g., lacrimal syringing). It may also be used during placement of a lacrimal tube/stent, or in procedures for the extraction of the cortex lentis or softer parts of the lens of the eye. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844505010023	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.64	Millimeter
Length	50	Millimeter