Euflexxa

GUDID 05060604130003

Injected into the knee to relieve the pain from osteoarthritis.

ACRE PHARMA LIMITED

Synovial fluid supplementation medium
Primary Device ID05060604130003
NIH Device Record Keyc202dfd9-70e1-4ebb-b058-da14809aa654
Commercial Distribution StatusIn Commercial Distribution
Brand NameEuflexxa
Version Model NumberNA
Company DUNS218668297
Company NameACRE PHARMA LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060604130003 [Primary]

FDA Product Code

MOZAcid, Hyaluronic, Intraarticular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-28
Device Publish Date2018-04-27

Devices Manufactured by ACRE PHARMA LIMITED

05060604130065 - Monovisc2019-02-14
05060604130041 - Synvisc2018-08-27
05060604130034 - Synvisc One2018-07-27 Inject into the knee to relieve the pain from osteoarthritis.
05060604130003 - Euflexxa2018-05-28Injected into the knee to relieve the pain from osteoarthritis.
05060604130003 - Euflexxa2018-05-28 Injected into the knee to relieve the pain from osteoarthritis.
05060604130010 - Orthovisc2018-05-28 Inject into the knee to relieve the pain caused by osteoarthritis.
05060604130027 - Supartz2018-05-28 Injected into the knee to relieve the pain from osteoarthritis.

Trademark Results [Euflexxa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EUFLEXXA
EUFLEXXA
76643024 3346569 Live/Registered
Ferring B.V.
2005-07-18
EUFLEXXA
EUFLEXXA
76642543 not registered Dead/Abandoned
Ferring B.V.
2005-07-08

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