GenVisc® 850 sodium hyaluronate
GUDID 10850653006013
GenVisc® 850 sodium hyaluronate (P140005) 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. GenVisc 850 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. GenVisc 850 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 Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium| Primary Device ID | 10850653006013 |
| NIH Device Record Key | 387e1353-45f3-426f-89f0-d62c6e19ce4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GenVisc® 850 sodium hyaluronate |
| Version Model Number | 50653-0006-01 |
| 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(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| info@orthogenrx.com | |
| Phone | +1(844)436-8472 |
| 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 | 00850653006016 [Primary] |
| GS1 | 10850653006013 [Package] Contains: 00850653006016 Package: [5 Units] In Commercial Distribution |
| GS1 | 20850653006010 [Package] Package: [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140005
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 | 2016-10-31 |
Devices Manufactured by ORTHOGENRX, INC
| 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 | 2018-07-06GenVisc® 850 sodium hyaluronate (P140005) 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. GenVisc 850 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. GenVisc 850 is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution). |
| 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 [GenVisc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENVISC 86156311 4973589 Live/Registered |
OrthogenRx, Inc. 2014-01-02 |
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