Monovisc - Crosslinked Sodium Hyaluronate 22 mg/mL - Anika Therapeutics, Inc.

Duns Number:807613393

Device Description: Crosslinked Sodium Hyaluronate 22 mg/mL

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More Product Details

Catalog Number

-

Brand Name

Monovisc

Version/Model Number

690016

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

-

Product Code Details

Product Code

MOZ

Product Code Name

Acid, Hyaluronic, Intraarticular

Device Record Status

Public Device Record Key

ae0edbd2-9ceb-4f2f-80f4-5ca5264f5d2d

Public Version Date

December 15, 2021

Public Version Number

1

DI Record Publish Date

December 07, 2021

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