Synvisc®

GUDID 00358468019103

Acid, Hyaluronic, Intraarticular

GENZYME CORPORATION

Synovial fluid supplementation medium
Primary Device ID00358468019103
NIH Device Record Key4dad8da6-3586-49bd-82f2-1e6817ab0608
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynvisc®
Version Model Number002390
Company DUNS098066215
Company NameGENZYME CORPORATION
Device Count3
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone+1(201)402-5217
Emailki.lee@genzyme.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100358468019103 [Primary]
GS120358468019107 [Unit of Use]

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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-25

Devices Manufactured by GENZYME CORPORATION

00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U
00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
00358468430120 - Seprafilm®2019-09-10 Barrier, Absorbable, Adhesion
00358468508621 - Seprafilm® Procedure Pack2019-09-10 Barrier, Absorbable, Adhesion
00358468638014 - Seprafilm® 4-section2019-09-10 Barrier, Absorbable, Adhesion
00358468664112 - Seprafilm® Single Site2019-09-10 Barrier, Absorbable, Adhesion
00358468664211 - Seprafilm® Small Incision2019-09-10 Barrier, Absorbable, Adhesion

Trademark Results [Synvisc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNVISC
SYNVISC
73597580 1418125 Live/Registered
BIOMATRIX, INC.
1986-05-08

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