Katalyst™ Bipolar Radial Head System 221001

GUDID M2482210011

KATALYST CASE BASE AND LID

INTEGRA LIFESCIENCES CORPORATION

Instrument tray

• Primary Device ID: M2482210011
• NIH Device Record Key: 1bdeb4e0-f54f-40fa-9f95-953a64cb1597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Katalyst™ Bipolar Radial Head System
• Version Model Number: 221001
• Catalog Number: 221001
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780279587 [Primary]
HIBCC	M2482210011 [Secondary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

[M2482210011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-21
• Device Publish Date: 2018-04-10

On-Brand Devices [Katalyst™ Bipolar Radial Head System]

• M2482210041: KATALYST Radial Head Sizing Wand Instrument Case
• M2482210031: KATALYST Radial Head Sizing Wand Instrument Case Lid
• M2482210011: KATALYST CASE BASE AND LID
• M2482216851: The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the fac
• M2482216801: The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the fac
• M2482216601: The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the fac
• M2482218001: The Katalyst Set Screw is used to lock the Radial Head and the Radial Stem in place.
• M2482216751: The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the fac
• M2482216651: The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the fac
• M2482214241: The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the fac
• M2482214211: The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the fac
• M2482214181: The Katalyst Radial Head restores the support and bearing surfaces of the radial head in the fac
• M2482216701: The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the fac