FMS OMNICUT 287433

GUDID 20886705022509

FMS OMNICUT Resection Blade 5.2mm SOFT TISSUE and BONE SHAVER BLADE FOR USE with FMS DUO System

DEPUY MITEK, LLC

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• Primary Device ID: 20886705022509
• NIH Device Record Key: 5685b2c5-96bd-464e-81a9-21e48e62755e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMS OMNICUT
• Version Model Number: 287433
• Catalog Number: 287433
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705022502 [Primary]
GS1	20886705022509 [Package]; Contains: 10886705022502; Package: PACKAGE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130912

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-07-04
• Device Publish Date: 2017-03-17

On-Brand Devices [FMS OMNICUT]

• 20886705022509: FMS OMNICUT Resection Blade 5.2mm SOFT TISSUE and BONE SHAVER BLADE FOR USE with FMS DUO System
• 20886705022493: FMS OMNICUT Resection Blade 4.2mm SOFT TISSUE and BONE SHAVER BLADE FOR USE with FMS DUO System
• 20886705022486: FMS OMNICUT Resection Blade 5.2mm SOFT TISSUE and BONE SHAVER BLADE
• 20886705022479: FMS OMNICUT Resection Blade 4.2mm SOFT TISSUE and BONE SHAVER BLADE