Optivisc - 0.8 mL, 12 mg/mL Sodium Hyaluronate - Anika Therapeutics, Inc.

Duns Number:807613393

Device Description: 0.8 mL, 12 mg/mL Sodium Hyaluronate

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Optivisc

Version/Model Number

600-105

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P000046

Product Code Details

Product Code

LZP

Product Code Name

Aid, Surgical, Viscoelastic

Device Record Status

Public Device Record Key

cfe035b4-1754-4e0e-888c-f48f8b343c8e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANIKA THERAPEUTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 15
3 A medical device with high risk that requires premarket approval 15