SYNVISC ONE

GUDID 15060432190009

Synovial fluid supplementation medium

Primary Device ID	15060432190009
NIH Device Record Key	1c61f887-52ac-43f0-a1bf-3da576e664d1
Commercial Distribution Status	In Commercial Distribution
Brand Name	SYNVISC ONE
Version Model Number	HYLAN GF-20
Company DUNS	219706976
Company Name	FCL HEALTH SOLUTIONS LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	15060432190009 [Primary]

MOZ	Acid, Hyaluronic, Intraarticular

Steralize Prior To Use	false
Device Is Sterile	true

15060432190009 - SYNVISC ONE	2018-03-29Acid, Hyaluronic, Intraarticular
15060432190009 - SYNVISC ONE	2018-03-29 Acid, Hyaluronic, Intraarticular
65060432190004 - SYNVISC	2018-03-29 injectable (hyaluronic acid, intra-articular)
35060432190003 - HYALGAN	2018-03-29 injectable (hyaluronic acid, intra-articular)
45060432190000 - Euflexxa	2018-03-29
75060432190001 - Orthovisc	2018-03-29
05060432190019 - Supartz	2018-03-29
05060432190026 - Monovisc	2018-03-29
05060432190033 - Radiesse	2018-03-29

Mark Image Registration \| Serial	Company Trademark Application Date
SYNVISC ONE 77228235 3521857 Live/Registered	Genzyme Corporation 2007-07-12
SYNVISC ONE 77171821 not registered Dead/Abandoned	Genzyme Corporation 2007-05-03