GenVisc® 850 sodium hyaluronate

GUDID 10850653006013

GenVisc® 850 sodium hyaluronate (P140005) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).

ORTHOGENRX, INC

Synovial fluid supplementation medium
Primary Device ID10850653006013
NIH Device Record Key387e1353-45f3-426f-89f0-d62c6e19ce4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenVisc® 850 sodium hyaluronate
Version Model Number50653-0006-01
Company DUNS079299998
Company NameORTHOGENRX, INC
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

Customer Support Contacts

Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com
Phone+1(844)436-8472
Emailinfo@orthogenrx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850653006016 [Primary]
GS110850653006013 [Package]
Contains: 00850653006016
Package: [5 Units]
In Commercial Distribution
GS120850653006010 [Package]
Package: [50 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-31

Devices Manufactured by ORTHOGENRX, INC

10850653006044 - TriVisc™ sodium hyaluronate2019-01-21 TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patient
10850653006013 - GenVisc® 850 sodium hyaluronate2018-07-06GenVisc® 850 sodium hyaluronate (P140005) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
10850653006013 - GenVisc® 850 sodium hyaluronate2018-07-06 GenVisc® 850 sodium hyaluronate (P140005) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients

Trademark Results [GenVisc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENVISC
GENVISC
86156311 4973589 Live/Registered
OrthogenRx, Inc.
2014-01-02
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