FDA.reportPublic FDA data

Euflexxa

Primary DI
07640128544210
Brand
Euflexxa
Company
FERRING PHARMACEUTICALS INC.
Model
4100
Device description
1% sodium hyaluronate
Published
2014-09-24
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
P010029001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010029001EUFLEXXA (1% SODIUM HYALURONATE)Ferring Pharmaceuticals, Inc.2004-12-03MOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640128544210PrimaryGS10
07640128544302Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640128544210076401285442107640128544210
07640128544302076401285443027640128544302

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)337-7464MedqueriesUS@ferring.com

Regulatory Flags#

DUNS number
103722955
Device count
3
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640180262657Rebyota 55566-9850-12023-02-24
07640180261018ZOMA-Jet10mg Demonstration Kit55566-1903-12018-08-01
07640180261001ZOMA-Jet5mg Demonstration Kit55566-1803-12018-08-01

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