Primary Device ID | 35060432190003 |
NIH Device Record Key | 65fe0f36-fa49-4113-b7e1-115af0e9d347 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HYALGAN |
Version Model Number | None |
Company DUNS | 219706976 |
Company Name | FCL HEALTH SOLUTIONS LTD |
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 | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 999-999-9999 |
info@fclhealth.com | |
Phone | 999-999-9999 |
info@fclhealth.com |
Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 35060432190003 [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 | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-05-26 |
15060432190009 - SYNVISC ONE | 2018-03-29 Acid, Hyaluronic, Intraarticular |
65060432190004 - SYNVISC | 2018-03-29 injectable (hyaluronic acid, intra-articular) |
35060432190003 - HYALGAN | 2018-03-29injectable (hyaluronic acid, intra-articular) |
35060432190003 - HYALGAN | 2018-03-29 injectable (hyaluronic acid, intra-articular) |
45060432190000 - Euflexxa | 2018-03-29 |
75060432190001 - Orthovisc | 2018-03-29 |
05060432190019 - Supartz | 2018-03-29 |
05060432190026 - Monovisc | 2018-03-29 |
05060432190033 - Radiesse | 2018-03-29 |
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 |