Supartz

GUDID 05060459970120

ALLY MEDICAL SUPPLIES LTD

Synovial fluid supplementation medium

• Primary Device ID: 05060459970120
• NIH Device Record Key: 2542a882-955f-4fa1-8abb-4cddaa21d0fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Supartz
• Version Model Number: NA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060459970120 [Primary]
GS1	5060459970137 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980044

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: 2016-09-13

Devices Manufactured by ALLY MEDICAL SUPPLIES LTD

• 5060459970014 - Synvisc: 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
• 05060459970120 - Supartz: 2018-07-06