FDA.reportPublic FDA data

TriLURON

Primary DI
M71389122087901SAM1
Brand
TriLURON
Company
FIDIA FARMACEUTICI SPA
Model
M71389122087901SAM1A
Catalog number
FID10000317
Device description
TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL - Professional Sample - Not for Sale
Published
2019-11-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOZAcid, Hyaluronic, Intraarticular

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180040000TRILURONFidia Farmaceutici S.P.A.2019-03-26MOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M71389122087901SAM1PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-749-2542compliance@fidiapharma.us

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 DIBrandModelCatalogPublished
M71389122179604A15HYALO GYN Vaginal Hydrating Gel, 30g Tube1796041796042016-11-01
M7131797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens1797041797042021-03-25
M7133797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample3797043797042021-03-25
M713891220750010HYMOVIS® ONE 32mg/4ml syringe89122-0750-0189122-0750-012025-11-07
M713FID075010HYMOVIS® ONE Professional Sample, 32mg/4ml syringeFID07501FID075012025-11-07
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFPRP40FPRP402025-10-31
M713FPRP200RICHPLAT ORTHO PRP SYSTEMFPRP20FPRP202021-03-25
M713COL2021COL-FID4 Care Collagen Wound DressingCOL202COL2022025-11-24
M71389122072412A1Hyalgan® Sodium Hyaluronate 2mL Vial89122-0724-1289122-0724-122015-07-31
M71389122087901A1TriLURONM71389122087901A1389122-0879-012019-11-04
M71389122072420A1Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL89122-0724-2089122-0724-202015-07-31
M713891220879010TRILURON89122-0879-0189122-0879-012024-05-07
M713891220724200Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL89122-0724-2089122-0724-202023-10-16
M713891220724120Hyalgan® Sodium Hyaluronate 2mL Vial89122-0724-1289122-0724-122023-09-13
M71389122049663A16Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe89122-0496-6389122-0496-632016-03-21
M713494290030100Hyalo4 Care Clear Hydrogel, 30g49429-0030-1049429-0030-102023-06-14
M713494290100350Hyalo4 Care Clear Hydrogel, 100g49429-0100-3549429-0100-352023-06-14
M713494440025080Hyalo4 Care Hydrogel, 25g49444-0025-0849444-0025-082023-06-14
M713494440100350Hyalo4 Care Hydrogel, 100g49444-0100-3549444-0100-352023-06-14
M713100004050HYALO GYN Vaginal Moisturizing Suppositories Sample10000405100004052021-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08437027710049SYNVISC ONESAIMA GLOBAL FARMA S.L.MOZ2024-11-13
08437027710056SYNVISCSAIMA GLOBAL FARMA S.L.MOZ2024-11-13
M713891220879010TRILURONFIDIA FARMACEUTICI SPAMOZ2024-05-07
00193493000753GenVisc 850 Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
00193493000760TriVisc Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
10193493000750GenVisc 850 Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
10193493000767TriVisc Sodium HyaluronateAvanos Medical, Inc.MOZ2024-03-06
M713891220724200Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mLFIDIA FARMACEUTICI SPAMOZ2023-10-16
10389130444418SUPARTZ FX sodium hyaluronateBIOVENTUS LLCMOZ2023-09-28