DUROLANE

GUDID 08437027710001

DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

SAIMA GLOBAL FARMA S.L.

Synovial fluid supplementation medium
Primary Device ID08437027710001
NIH Device Record Keyf8e3daab-8ab4-4c9d-9c2a-f351fbe96b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUROLANE
Version Model Number1082020
Company DUNS468910220
Company NameSAIMA GLOBAL FARMA S.L.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108437027710001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOZAcid, Hyaluronic, Intraarticular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

Devices Manufactured by SAIMA GLOBAL FARMA S.L.

08437027710001 - DUROLANE2024-11-21DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
08437027710001 - DUROLANE2024-11-21 DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock
08437027710018 - MONOVISC2024-11-21 MONOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in th
08437027710025 - ORTHOVISC2024-11-21 ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in t
08437027710049 - SYNVISC ONE2024-11-21 SYNVISC ONE (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hya
08437027710056 - SYNVISC2024-11-21 SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluro

Trademark Results [DUROLANE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DUROLANE
DUROLANE
86950374 5196963 Live/Registered
Bioventus LLC
2016-03-23
DUROLANE
DUROLANE
77781493 3762687 Dead/Cancelled
BIOVENTUS LLC
2009-07-15
DUROLANE
DUROLANE
76119661 2753628 Dead/Cancelled
Q-MED AB
2000-08-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.