Primary Device ID | M71389122072412A1 |
NIH Device Record Key | 476a27f7-e88a-41a2-b28b-b75c8725372e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hyalgan® Sodium Hyaluronate 2mL Vial |
Version Model Number | 89122-0724-12 |
Catalog Number | 89122-0724-12 |
Company DUNS | 428453013 |
Company Name | FIDIA FARMACEUTICI SPA |
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 |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us | |
Phone | 9735776202 |
regulatory@fidiapharma.us |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Special Storage Condition, Specify | Between 0 and 0 *Do Not Freeze |
Special Storage Condition, Specify | Between 0 and 0 *Store Below 77°F |
Special Storage Condition, Specify | Between 0 and 0 *Store in original packaging (protected from light) |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M71389122072412A1 [Primary] |
MOZ | Acid, Hyaluronic, Intraarticular |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-03-25 |
Device Publish Date | 2015-07-31 |
M71389122072412A1 | Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain i |
M713891220724120 | Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain i |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYALGAN 79202959 5388830 Live/Registered |
Fidia Farmaceutici S.p.A. 2016-07-19 |
HYALGAN 73585251 1420772 Live/Registered |
FIDIA S.P.A. 1986-02-28 |