Duns Number:690584057
Device Description: Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain 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.
Catalog Number
00-1111-001-00
Brand Name
Gel-One® Cross-linked Hyaluronate
Version/Model Number
00-1111-001-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 05, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020,P080020
Product Code
MOZ
Product Code Name
Acid, Hyaluronic, Intraarticular
Public Device Record Key
4aae65b2-5381-4f58-976e-3f5f1bf2aee8
Public Version Date
March 22, 2021
Public Version Number
11
DI Record Publish Date
September 17, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 3 |