GenVisc 850 Sodium Hyaluronate 50653-0006-01

GUDID 10193493000750

GenVisc 850

Avanos Medical, Inc.

Synovial fluid supplementation medium
Primary Device ID10193493000750
NIH Device Record Keyd7023f52-71c7-4851-8745-fab6bc7ff4ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenVisc 850 Sodium Hyaluronate
Version Model Number50653-0006-01
Catalog Number50653-0006-01
Company DUNS079375431
Company NameAvanos Medical, 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)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM
Phone+1(844)428-2667
EmailPIQ@AVANOS.COM

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100193493000753 [Primary]
GS110193493000750 [Package]
Contains: 00193493000753
Package: CS [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-14
Device Publish Date2024-03-06

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