Katalyst™ Bipolar Radial Head System 225918

GUDID M2482259181

Katalyst™ Bipolar Radial Head System 18mm Radial Head Sizing Wand

Ascension Orthopedics, Inc.

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• Primary Device ID: M2482259181
• NIH Device Record Key: a7125489-6c60-4f7a-b969-0fea63b477d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Katalyst™ Bipolar Radial Head System
• Version Model Number: 225918
• Catalog Number: 225918
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780363941 [Primary]
HIBCC	M2482259181 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032806

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

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

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

[M2482259181]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-03-04
• Device Publish Date: 2018-05-11

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

• M2482259241: Katalyst™ Bipolar Radial Head System 24mm Radial Head Sizing Wand
• M2482259211: Katalyst™ Bipolar Radial Head System 21mm Radial Head Sizing Wand
• M2482259181: Katalyst™ Bipolar Radial Head System 18mm Radial Head Sizing Wand
• M248KATALYSTWANDIMP1: Katalyst Radial Head Sizing Wand Instruments
• M2482243241: KATALYST TRIAL HEAD 24MM
• M2482243211: KATALYST TRIAL HEAD 21MM
• M2482243181: KATALYST TRIAL HEAD 18MM
• M2482241751: TRIAL STEM SHAFT 7.5MM
• M2482241651: TRIAL STEM SHAFT 6.5MM
• M2482240001: DEMO IMPLANT, RADIAL HEAD
• M2482270011: KATALYST NYLON DEMO HOLDER
• M2482253751: 7.5MM BROACH LONG
• M2482253651: 6.5MM BROACH LONG
• M2482260001: Katalyst™ Bipolar Radial Head System STARTER AWL
• M2482259001: Katalyst™ Bipolar Radial Head System HEAD SIZING TEMPLATE
• M2482256001: Katalyst™ Bipolar Radial Head System CUTTING TEMPLATE
• M248225405KMI1: Katalyst™ Bipolar Radial Head System FIRST SPACER
• M248225400KMI1: Katalyst™ Bipolar Radial Head System SPACER 2MM