FDA.reportPublic FDA data

Gel-One® Cross-linked Hyaluronate

Primary DI
04987541300911
Brand
Gel-One® Cross-linked Hyaluronate
Company
SEIKAGAKU CORPORATION
Model
00-1111-001-00
Catalog number
00-1111-001-00
Device description
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
Published
2020-01-15
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#

Submission, Supplement table
SubmissionSupplement
P080020012
P080020013
P080020014
P080020015
P080020016
P080020017
P080020018
P080020019
P080020020
P080020021
P080020022
P080020023
P080020024
P080020025
P080020027
P080020028
P080020029
P080020030
P080020031
P080020032
P080020033
P080020035
P080020036
P080020037
P080020038
P080020039
P080020040
P080020042
P080020043
P080020044
P080020045
P080020046
P080020047
P080020048
P080020049
P080020051
P080020052
P080020053
P080020054

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080020012GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020013GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020014GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020015GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020016GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020017GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020018GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020019GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020020GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020021GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020022GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020023GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020024GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020025GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020027GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020028GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020029GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020030GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020031GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020032GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020033GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020035GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020036GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020037GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020038GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020039GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020040GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020042GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020043GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020044GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020045GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020046GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020047GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020048GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020049GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020051GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020052GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020053GEL-ONESeikagaku Corp.2011-03-22MOZ
P080020054GEL-ONESeikagaku Corp.2011-03-22MOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987541300911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987541300911049875413009114987541300911

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
04987541301314VISCO-3 sodium hyaluronate00-1111-001-0300-1111-001-032017-03-22
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