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 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| info@orthogenrx.com | |
| Phone | +1(877)517-5445 |
| 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 |
Trademark Results [TriVisc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIVISC 87307422 5716124 Live/Registered |
OrthogenRx, Inc. 2017-01-19 |
 TRIVISC 77702826 not registered Dead/Abandoned |
Lindstrom, Richard L. 2009-03-31 |
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