Gel-One® Cross-linked Hyaluronate 00-1111-001-00
GUDID 00087541300912
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
Synovial fluid supplementation medium| Primary Device ID | 00087541300912 |
| NIH Device Record Key | 4aae65b2-5381-4f58-976e-3f5f1bf2aee8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gel-One® Cross-linked Hyaluronate |
| Version Model Number | 00-1111-001-00 |
| Catalog Number | 00-1111-001-00 |
| Company DUNS | 690584057 |
| Company Name | SEIKAGAKU CORPORATION |
| 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 | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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| Phone | 8003482759 |
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Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00087541300912 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P080020
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 | 7 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2014-09-17 |
On-Brand Devices [Gel-One® Cross-linked Hyaluronate]
| 00087541300912 | Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in os |
| 04987541300911 | Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in os |
Trademark Results [Gel-One]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEL-ONE 87384987 5462006 Live/Registered |
SEIKAGAKU KOGYO KABUSHIKI KAISHA 2017-03-24 |
 GEL-ONE 77181799 3687961 Live/Registered |
Seikagaku Kogyo Kabushiki Kaisha 2007-05-15 |
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