Home GUDID M713891220724200 Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
Primary DI M713891220724200
Brand Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL
Company FIDIA FARMACEUTICI SPA
Model 89122-0724-20
Catalog number 89122-0724-20
Device description 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.
Published 2023-10-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MOZ Acid, Hyaluronic, Intraarticular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MOZ Acid, Hyaluronic, Intraarticular Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M713891220724200 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Synovial fluid supplementation medium A sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do Not Freeze Special Storage Condition, Specify 0 0 Store Below 77°F Special Storage Condition, Specify 0 0 Store in original packaging (protected from light)
Regulatory Flags# DUNS number 428453013 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M71389122179604A15 HYALO GYN Vaginal Hydrating Gel, 30g Tube 179604 179604 2016-11-01 M7131797040 Hyalo GYN Vaginal Hydrating Gel - Made without Parabens 179704 179704 2021-03-25 M7133797040 Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample 379704 379704 2021-03-25 M713891220750010 HYMOVIS® ONE 32mg/4ml syringe 89122-0750-01 89122-0750-01 2025-11-07 M713FID075010 HYMOVIS® ONE Professional Sample, 32mg/4ml syringe FID07501 FID07501 2025-11-07 M713FPRP400 RICHPLAT ORTHO 40 PRP SYSTEM FPRP40 FPRP40 2025-10-31 M713FPRP200 RICHPLAT ORTHO PRP SYSTEM FPRP20 FPRP20 2021-03-25 M713COL2021 COL-FID4 Care Collagen Wound Dressing COL202 COL202 2025-11-24 M71389122072412A1 Hyalgan® Sodium Hyaluronate 2mL Vial 89122-0724-12 89122-0724-12 2015-07-31 M71389122087901A1 TriLURON M71389122087901A13 89122-0879-01 2019-11-04 M71389122072420A1 Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL 89122-0724-20 89122-0724-20 2015-07-31 M713891220879010 TRILURON 89122-0879-01 89122-0879-01 2024-05-07 M713891220724120 Hyalgan® Sodium Hyaluronate 2mL Vial 89122-0724-12 89122-0724-12 2023-09-13 M71389122049663A16 Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe 89122-0496-63 89122-0496-63 2016-03-21 M713494290030100 Hyalo4 Care Clear Hydrogel, 30g 49429-0030-10 49429-0030-10 2023-06-14 M713494290100350 Hyalo4 Care Clear Hydrogel, 100g 49429-0100-35 49429-0100-35 2023-06-14 M713494440025080 Hyalo4 Care Hydrogel, 25g 49444-0025-08 49444-0025-08 2023-06-14 M713494440100350 Hyalo4 Care Hydrogel, 100g 49444-0100-35 49444-0100-35 2023-06-14 M713100004050 HYALO GYN Vaginal Moisturizing Suppositories Sample 10000405 10000405 2021-03-25 M713891220496010 Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack 89122-0496-01 89122-0496-01 2022-09-26
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