Hyalgan® Sodium Hyaluronate 2mL Vial 89122-0724-12

GUDID M71389122072412A1

Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.

FIDIA FARMACEUTICI SPA

Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium
Primary Device IDM71389122072412A1
NIH Device Record Key476a27f7-e88a-41a2-b28b-b75c8725372e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyalgan® Sodium Hyaluronate 2mL Vial
Version Model Number89122-0724-12
Catalog Number89122-0724-12
Company DUNS428453013
Company NameFIDIA FARMACEUTICI SPA
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

Customer Support Contacts

Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us
Phone9735776202
Emailregulatory@fidiapharma.us

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Store Below 77°F
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original packaging (protected from light)

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM71389122072412A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOZAcid, Hyaluronic, Intraarticular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-03-25
Device Publish Date2015-07-31

On-Brand Devices [Hyalgan® Sodium Hyaluronate 2mL Vial]

M71389122072412A1Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain i
M713891220724120Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain i

Trademark Results [Hyalgan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYALGAN
HYALGAN
79202959 5388830 Live/Registered
Fidia Farmaceutici S.p.A.
2016-07-19
HYALGAN
HYALGAN
73585251 1420772 Live/Registered
FIDIA S.P.A.
1986-02-28

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