ORTHOVISC

GUDID 08437027710025

ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. ORTHOVISC 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 ID08437027710025
NIH Device Record Key2fed24c2-95ce-4ebe-90d8-813b2c865c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOVISC
Version Model Number277500
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 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108437027710025 [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 - DUROLANE2024-11-21 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 - ORTHOVISC2024-11-21ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. ORTHOVISC 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.
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 [ORTHOVISC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOVISC
ORTHOVISC
74079098 1834288 Live/Registered
ANIKA THERAPEUTICS, INC.
1990-07-17
ORTHOVISC
ORTHOVISC
73831857 not registered Dead/Abandoned
MEDCHEM PRODUCTS, INC.
1989-10-16

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