HYALGAN

GUDID 35060432190003

injectable (hyaluronic acid, intra-articular)

FCL HEALTH SOLUTIONS LTD

Synovial fluid supplementation medium
Primary Device ID35060432190003
NIH Device Record Key65fe0f36-fa49-4113-b7e1-115af0e9d347
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYALGAN
Version Model NumberNone
Company DUNS219706976
Company NameFCL HEALTH SOLUTIONS LTD
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailinfo@fclhealth.com
Phone999-999-9999
Emailinfo@fclhealth.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS135060432190003 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2015-05-26

Devices Manufactured by FCL HEALTH SOLUTIONS LTD

15060432190009 - SYNVISC ONE2018-03-29 Acid, Hyaluronic, Intraarticular
65060432190004 - SYNVISC2018-03-29 injectable (hyaluronic acid, intra-articular)
35060432190003 - HYALGAN2018-03-29injectable (hyaluronic acid, intra-articular)
35060432190003 - HYALGAN2018-03-29 injectable (hyaluronic acid, intra-articular)
45060432190000 - Euflexxa2018-03-29
75060432190001 - Orthovisc2018-03-29
05060432190019 - Supartz2018-03-29
05060432190026 - Monovisc2018-03-29
05060432190033 - Radiesse2018-03-29

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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