Synvisc-One®

GUDID 20358468019114

Acid, Hyaluronic, Intraarticular

GENZYME CORPORATION

Synovial fluid supplementation medium
Primary Device ID20358468019114
NIH Device Record Keybe653c1a-a962-43aa-bfcd-6da7ad2dc7e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynvisc-One®
Version Model Number002401
Company DUNS098066215
Company NameGENZYME CORPORATION
Device Count1
DM Exempttrue
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

Phone+1(201)402-5451
Emailnancy.immel@genzyme.com
Phone+1(201)402-5451
Emailnancy.immel@genzyme.com

Device Dimensions

Total Volume6 Milliliter
Device Size Text, specify0
Total Volume6 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120358468019114 [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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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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-One]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNVISC-ONE
SYNVISC-ONE
77171858 3651732 Live/Registered
Genzyme Corporation
2007-05-03

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