FDA.report

Synvisc One

Primary DI
05060519180032
Brand
Synvisc One
Company
PROPHARMA-UK LTD
Model
NA
Published
2017-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MOZAcid, Hyaluronic, Intraarticular

Product Code Classifications

CodeDeviceSpecialtyClass
MOZAcid, Hyaluronic, IntraarticularUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060519180049PackageGS13In Commercial Distribution
05060519180032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060519180049050605191800495060519180049
05060519180032050605191800325060519180032

GMDN Terms

TermDefinition
Synovial fluid supplementation mediumA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
221768159
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060519180001HyalganNA2017-02-22
05060519180018OrthoviscNA2017-02-22
05060519180025SupartzNA2017-02-22
05060519180056EuflexxaNA2017-02-22

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05065026658005DurolaneMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
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05065026658036OrthoviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658043SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658074SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
08052570475131SupartzDAMBO SRLMOZ2025-11-26
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08052570473229MonoviscDAMBO SRLMOZ2025-09-25
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03770034301158SynviscUNIVERDERMMOZ2025-03-13
03770034301172SynviscUNIVERDERMMOZ2025-03-13
08437027710001DUROLANESAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710018MONOVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710025ORTHOVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710049SYNVISC ONESAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710056SYNVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
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10389130444418SUPARTZ FX sodium hyaluronateBIOVENTUS LLCMOZ2023-09-28
M713891220724120Hyalgan® Sodium Hyaluronate 2mL VialFIDIA FARMACEUTICI SPAMOZ2023-09-13
M713891220496010Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 packFIDIA FARMACEUTICI SPAMOZ2022-09-26
00888867413689Arthrex®ARTHREX, INC.MOZ2022-02-01
00817337000104MonoviscAnika Therapeutics, Inc.MOZ2021-12-07
00817337000111OrthoviscAnika Therapeutics, Inc.MOZ2021-12-07
04987541300911Gel-One® Cross-linked HyaluronateSEIKAGAKU CORPORATIONMOZ2020-01-15
04260648380094DurolaneArcera GmbHMOZ2019-12-06