Synvisc-One®

GUDID 20358468019114

Acid, Hyaluronic, Intraarticular

GENZYME CORPORATION

Synovial fluid supplementation medium

• Primary Device ID: 20358468019114
• NIH Device Record Key: be653c1a-a962-43aa-bfcd-6da7ad2dc7e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synvisc-One®
• Version Model Number: 002401
• Company DUNS: 098066215
• Company Name: GENZYME CORPORATION
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(201)402-5451
• Email: nancy.immel@genzyme.com
• Phone: +1(201)402-5451
• Email: nancy.immel@genzyme.com

Device Dimensions

• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20358468019114 [Primary]

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: 2014-09-24

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