Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL - Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL - FIDIA FARMACEUTICI SPA

Duns Number:428453013

Device Description: Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment o Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

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More Product Details

Catalog Number

89122-0724-20

Brand Name

Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL

Version/Model Number

89122-0724-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P950027

Product Code Details

Product Code

MOZ

Product Code Name

Acid, Hyaluronic, Intraarticular

Device Record Status

Public Device Record Key

ddad4099-2f1d-470f-b65a-af8738f6baeb

Public Version Date

March 25, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2015

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