GenVisc 850 Sodium Hyaluronate 50653-0006-01

GUDID 10193493000750

GenVisc 850

Avanos Medical, Inc.

Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium Synovial fluid supplementation medium

• Primary Device ID: 10193493000750
• NIH Device Record Key: d7023f52-71c7-4851-8745-fab6bc7ff4ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenVisc 850 Sodium Hyaluronate
• Version Model Number: 50653-0006-01
• Catalog Number: 50653-0006-01
• Company DUNS: 079375431
• Company Name: Avanos Medical, Inc.
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193493000753 [Primary]
GS1	10193493000750 [Package]; Contains: 00193493000753; Package: CS [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140005

FDA Product Code

• MOZ: Acid, hyaluronic, intraarticular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

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• 00193494000851 - ambiT® "PreSet" Ambulatory Infusion Pump: 2024-03-07 ambIT* Pain Control System - Basic
• 00193494001285 - ambiT® "PreSet" Ambulatory Infusion Pump: 2024-03-07 ambIT* Pain Control System - Spike Cassette with Filter
• 00193494001292 - ambIT* PIB-PCA v1.5 System w/Male Filter Cass: 2024-03-07 ambIT* PIB-PCA v1.5 System w/Male Filter Cass