Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe - HYMOVIS® is based on an ultra-pure hyaluronan - FIDIA FARMACEUTICI SPA

Duns Number:428453013

Device Description: HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to in HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.

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More Product Details

Catalog Number

FID185704

Brand Name

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe

Version/Model Number

FID185704

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2022

Issuing Agency

In HIBCC

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

P150010,P150010

Product Code Details

Product Code

MOZ

Product Code Name

Acid, Hyaluronic, Intraarticular

Device Record Status

Public Device Record Key

452f19bf-4491-4777-ae73-24514dbe4f5b

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

February 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIDIA FARMACEUTICI SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8
3 A medical device with high risk that requires premarket approval 5