VISCO-3 sodium hyaluronate

Primary DI
04987541301314
Brand
VISCO-3 sodium hyaluronate
Company
SEIKAGAKU CORPORATION
Model
00-1111-001-03
Catalog number
00-1111-001-03
Device description
VISCO-3 (P980044/S027) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.VISCO-3 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. VISCO-3 is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
Published
2017-03-22
Public version status
Update
Distribution status
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#

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980044027SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044028SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044032SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044033SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044034SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044035SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044036SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044037SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044038SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044040SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044041SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044042SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044043SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044045SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044046SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044047SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044048SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044049SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044050SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044051SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044053SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044054SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044055SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044056SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044057SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044058SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044059SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044062SUPARTZ FXSeikagaku Corp.2001-01-24MOZ
P980044065SUPARTZ FXSeikagaku Corp.2001-01-24MOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14987541301311PackageGS13In Commercial Distribution
04987541301314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1498754130131114987541301311
04987541301314049875413013144987541301314

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 Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5743724999xxx@xxx.xxx
8003482759xxx@xxx.xxx

Regulatory Flags#

DUNS number
690584057
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M717715644440SUPARTZ FX sodium hyaluronate89130-4444-17156-44442017-01-31
04987541300911Gel-One® Cross-linked Hyaluronate00-1111-001-0000-1111-001-002020-01-15
00087541300912Gel-One® Cross-linked Hyaluronate00-1111-001-0000-1111-001-002014-09-17
M717715655550SUPARTZ® sodium hyaluronate89130-5555-017156-55552017-01-31

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