FDA.reportPublic FDA data

Monovisc

Primary DI
08057607270062
Brand
Monovisc
Company
NUVARA SRL
Model
N/A
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MOZAcid, Hyaluronic, Intraarticular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOZAcid, Hyaluronic, IntraarticularUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057607270062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057607270062080576072700628057607270062

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
302780450
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057607270017DurolaneN/A2026-10-15
08057607270024EuflexxaN/A2026-10-15
08057607270031Juvederm VolbellaN/A2026-10-15
08057607270048Juvederm VoluxN/A2026-10-15
08057607270055Juvederm VolumaN/A2026-10-15
08057607270079OrthoviscN/A2026-10-15
08057607270086RadiesseN/A2026-10-15
08057607270093Restylane LidoN/A2026-10-15
08057607270109Restylane LyftN/A2026-10-15
08057607270116Restylane RefyneN/A2026-10-15
08057607270123Restylane KysseN/A2026-10-15
08057607270130Restylane DefyneN/A2026-10-15
08057607270147SculptraN/A2026-10-15
08057607270161SupartzN/A2026-10-15
08057607270178SynviscN/A2026-10-15
08057607270192Synvisc OneN/A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057607270017DurolaneNUVARA SRLMOZ2026-10-15
08057607270024EuflexxaNUVARA SRLMOZ2026-10-15
08057607270079OrthoviscNUVARA SRLMOZ2026-10-15
08057607270161SupartzNUVARA SRLMOZ2026-10-15
08057607270178SynviscNUVARA SRLMOZ2026-10-15
08057607270192Synvisc OneNUVARA SRLMOZ2026-10-15
00860014587504GenVisc® 850Channel-Markers Medical LLCMOZ2026-06-19
04262487270031DurolanePharmamondis GmbHMOZ2026-06-10
04262487270048MonoviscPharmamondis GmbHMOZ2026-06-10
05065026658012EuflexxaMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658050SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658005DurolaneMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658067EuflexxaMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658029MonoviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658036OrthoviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658043SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
05065026658074SynviscMAPLESTONE DEVELOPMENTS LIMITEDMOZ2026-03-04
08052570475131SupartzDAMBO SRLMOZ2025-11-26
M713891220750010HYMOVIS® ONE 32mg/4ml syringeFIDIA FARMACEUTICI SPAMOZ2025-11-07
M713FID075010HYMOVIS® ONE Professional Sample, 32mg/4ml syringeFIDIA FARMACEUTICI SPAMOZ2025-11-07
08052570473441EuflexxaDAMBO SRLMOZ2025-09-25
08052570473212DurolaneDAMBO SRLMOZ2025-09-25
08052570473229MonoviscDAMBO SRLMOZ2025-09-25
08052570477654EuflexxaDAMBO SRLMOZ2025-09-25
03770034301165SynviscUNIVERDERMMOZ2025-03-13
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