FDA.reportPublic FDA data

Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe

Primary DI
M71389122049663SAM1
Brand
Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe
Company
FIDIA FARMACEUTICI SPA
Model
FID185704
Catalog number
FID185704
Device description
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
Published
2017-02-12
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
P150010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150010000HYMOVISFidia Farmaceutici2015-08-28MOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M71389122049663SAM1PrimaryHIBCC0
M71389122049663SAM0Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

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
866-749-2542customerservice@fidiapharma.us

Regulatory Flags#

DUNS number
428453013
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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M7133797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample3797043797042021-03-25
M713891220750010HYMOVIS® ONE 32mg/4ml syringe89122-0750-0189122-0750-012025-11-07
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M713FPRP200RICHPLAT ORTHO PRP SYSTEMFPRP20FPRP202021-03-25
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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

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