SYNOJOYNT 57844-181

GUDID 30357844181138

prefilled syringe

TEVA PHARMACEUTICALS USA, INC.

Synovial fluid supplementation medium

• Primary Device ID: 30357844181138
• NIH Device Record Key: c659f2e0-66cc-4069-a22a-ee869cc6f828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNOJOYNT
• Version Model Number: 57844-181
• Catalog Number: 57844-181
• Company DUNS: 001627975
• Company Name: TEVA PHARMACEUTICALS USA, INC.
• Device Count: 3
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)838-2872
• Email: TevaCS@tevapharm.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357844181137 [Primary]
GS1	00357844181212 [Unit of Use]
GS1	30357844181138 [Package]; Contains: 00357844181137; Package: Shipping Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170016

FDA Product Code

• MOZ: Acid, hyaluronic, intraarticular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-16
• Device Publish Date: 2019-05-08