Monovisc - Arcera GmbH

Duns Number:341558403

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More Product Details

Catalog Number

-

Brand Name

Monovisc

Version/Model Number

N/A

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

1782876f-4d35-44b9-930b-4766a63e7f49

Public Version Date

July 19, 2019

Public Version Number

1

DI Record Publish Date

July 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARCERA GMBH" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 4