Optivisc

GUDID 00866142000038

0.8 mL, 12 mg/mL Sodium Hyaluronate

Anika Therapeutics, Inc.

Vitreous/aqueous humour replacement medium, intraoperative
Primary Device ID00866142000038
NIH Device Record Keycfe035b4-1754-4e0e-888c-f48f8b343c8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptivisc
Version Model Number600-105
Company DUNS807613393
Company NameAnika Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100866142000038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZPAid, Surgical, Viscoelastic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-10-15

Devices Manufactured by Anika Therapeutics, Inc.

M06760001020 - Integrity Implant Fixation Kit2023-11-22 Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.
M06760001180 - Integrity Delivery Instrument, Bone Staple2023-11-22 Integrity bone staple delivery instrument, single-use
M06760001200 - Integrity Delivery Instrument, Tissue Tack2023-11-22 Integrity tissue tack delivery instrument, single use
00817337000241 - Integrity Implant2023-11-17 Integrity Implant, 20mm x 25mm
00817337000258 - Integrity Implant 2023-11-17 Integrity Implant, 25mmx30mm
M06760001220 - Integrity Cannula/Obturator Kit2023-11-17 Integrity Cannula and Obturator, single-use
08033549791063 - Epifilm Otologic2022-02-14 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na
00817337000128 - Ophthalin2022-01-06 0.8 ml, 1.2% OVD Sodium Hyaluronate

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