Synvisc®

GUDID 00358468019103

Acid, Hyaluronic, Intraarticular

GENZYME CORPORATION

Synovial fluid supplementation medium

• Primary Device ID: 00358468019103
• NIH Device Record Key: 4dad8da6-3586-49bd-82f2-1e6817ab0608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synvisc®
• Version Model Number: 002390
• Company DUNS: 098066215
• Company Name: GENZYME CORPORATION
• Device Count: 3
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: +1(201)402-5217
• Email: ki.lee@genzyme.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358468019103 [Primary]
GS1	20358468019107 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P940015

FDA Product Code

• MOZ: Acid, hyaluronic, intraarticular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-25

Devices Manufactured by GENZYME CORPORATION

• 00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US: 2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
• 00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U: 2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U
• 00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US: 2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
• 00358468430120 - Seprafilm®: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468508621 - Seprafilm® Procedure Pack: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468638014 - Seprafilm® 4-section: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468664112 - Seprafilm® Single Site: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468664211 - Seprafilm® Small Incision: 2019-09-10 Barrier, Absorbable, Adhesion