Euflexxa
GUDID 07640128544210
1% sodium hyaluronate
FERRING PHARMACEUTICALS 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 | 07640128544210 |
| NIH Device Record Key | 58bc7279-f90e-40c8-88bc-1d8e67767d6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Euflexxa |
| Version Model Number | 4100 |
| Company DUNS | 103722955 |
| Company Name | FERRING PHARMACEUTICALS INC. |
| Device Count | 3 |
| DM Exempt | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com | |
| Phone | +1(888)337-7464 |
| MedqueriesUS@ferring.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640128544210 [Primary] |
| GS1 | 07640128544302 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010029
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 | 2014-09-24 |
Devices Manufactured by FERRING PHARMACEUTICALS INC.
| 07640180262657 - Rebyota | 2023-03-06 Administration Set for use with Rebyota |
| 07640180261018 - ZOMA-Jet | 2021-08-19 Needle-free delivery device for use with ZOMACTON (somatropin) for Injection 10mg vial, 7 Head A's, Carry Case and User Manual. |
| 07640180261001 - ZOMA-Jet | 2019-07-22 Needle-fre4e delivery device for use with ZOMACTON (somatropin) for Injection 5mg vial, 5 Head A's, Carry Case and User Manual. |
| 07640128544210 - Euflexxa | 2018-07-061% sodium hyaluronate |
| 07640128544210 - Euflexxa | 2018-07-06 1% sodium hyaluronate |
Trademark Results [Euflexxa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EUFLEXXA 76643024 3346569 Live/Registered |
Ferring B.V. 2005-07-18 |
 EUFLEXXA 76642543 not registered Dead/Abandoned |
Ferring B.V. 2005-07-08 |
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