N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00850003089034
• Version / Model: 7003
• Catalog Number: 7003
• Company Name: Optalmed, LLC
• Labeler DUNS: 037077801
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2021-02-08
• Public Version: 1
• Public Version Date: 2021-02-16
• Public Version Status: New
• Public Device Record Key: 75a0296c-5bb6-4704-a1de-94bf8b726471

Device Description

Reusable Iris Retractors, 1 set of 6 retractors

Device Characteristics

• Single Use: No
• 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: 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
HOC	Clip, Iris Retractor	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63431	Intraocular retractor, reusable	A 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 small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850003089218	GS1
Primary	00850003089034	GS1