TriVisc™ sodium hyaluronate

GUDID 10850653006044

TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. TriVisc is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. TriVisc is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).

ORTHOGENRX, INC

Synovial fluid supplementation medium

• Primary Device ID: 10850653006044
• NIH Device Record Key: 6a9366eb-d516-479f-ba7a-3bd92979f6df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVisc™ sodium hyaluronate
• Version Model Number: 50653-0006-04
• Company DUNS: 079299998
• Company Name: ORTHOGENRX, INC
• 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: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com
• Phone: +1(877)517-5445
• Email: info@orthogenrx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850653006047 [Primary]
GS1	10850653006044 [Package]; Contains: 00850653006047; Package: bundle [3 Units]; In Commercial Distribution
GS1	20850653006041 [Package]; Package: case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160057

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: 2019-01-21
• Device Publish Date: 2018-12-20

Devices Manufactured by ORTHOGENRX, INC

• 10850653006044 - TriVisc™ sodium hyaluronate: 2019-01-21TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. TriVisc is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. TriVisc is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
• 10850653006044 - TriVisc™ sodium hyaluronate: 2019-01-21 TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patient
• 10850653006013 - GenVisc® 850 sodium hyaluronate: 2018-07-06 GenVisc® 850 sodium hyaluronate (P140005) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients