Ophthalin

Basic Information

• Brand Name: Ophthalin
• Primary DI: 00817337000128
• Version / Model: 6000080
• Company Name: Anika Therapeutics, Inc.
• Labeler DUNS: 807613393
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-29
• Public Version: 1
• Public Version Date: 2022-01-06
• Public Version Status: New
• Public Device Record Key: 8d572fbe-25e0-4ba7-88d9-0a3e1938060d

Device Description

0.8 ml, 1.2% OVD Sodium Hyaluronate

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: 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
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	886.4275	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35907	Vitreous/aqueous humour replacement medium, intraoperative	A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817337000128	GS1

Premarket Submissions

Submission Number	Supplement Number
P000046	030