Synvisc One

GUDID 05060459970021

ALLY MEDICAL SUPPLIES LTD

Synovial fluid supplementation medium

• Primary Device ID: 05060459970021
• NIH Device Record Key: 525fe674-78d0-406e-be17-e57991f06404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synvisc One
• Version Model Number: None
• Company DUNS: 220744126
• Company Name: ALLY MEDICAL SUPPLIES 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

Customer Support Contacts

• Phone: 516-206-1003
• Email: jeff@allymedicalsupplies.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060459970021 [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: 2015-10-23

Devices Manufactured by ALLY MEDICAL SUPPLIES LTD

• 5060459970014 - Synvisc: 2018-07-06
• 05060459970021 - Synvisc One: 2018-07-06
• 05060459970021 - Synvisc One: 2018-07-06
• 05060459970038 - Orthovisc: 2018-07-06
• 05060459970045 - Euflexxa: 2018-07-06
• 05060459970052 - Hyalgan: 2018-07-06
• 05060459970090 - Monovisc: 2018-07-06
• 05060459970120 - Supartz: 2018-07-06