Fiber Optic Light Guide

Basic Information

• Brand Name: Fiber Optic Light Guide
• Primary DI: 00853480006129
• Version / Model: Iris Retractor, 20 ga
• Catalog Number: TR9809-11
• Company Name: ESCALON MEDICAL CORP.
• Labeler DUNS: 879144426
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-14
• Public Version: 3
• Public Version Date: 2018-06-11
• Public Version Status: Update
• Public Device Record Key: 64a51306-669d-49f8-b082-26a68839968f

Device Description

Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction of the iris for optimal visualization of anterior vitreous. 20 ga, with Universal connector. Sterile, single-use.

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: Yes
• 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
HNI	Retractor, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46698	Intraocular retractor, single-use	A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10853480006126	GS1	Box	5	In Commercial Distribution
Primary	00853480006129	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius