284107

GUDID 10886705017089

Hand Control Interface LINVATEC ApeX

DEPUY MITEK, LLC

Arthroscopic shaver system, electrically-powered

• Primary Device ID: 10886705017089
• NIH Device Record Key: c1adc1b8-93d8-4138-bba4-fe6bfd638122
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 284107
• Catalog Number: 284107
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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)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	10886705017089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954465

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

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

Devices Manufactured by DEPUY MITEK, LLC

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• 20886705011039 - STRAIGHTSHOT: 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm
• 20886705011060 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 7.5mm
• 20886705011077 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm
• 20886705011084 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm
• 20886705011091 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm
• 20886705011107 - NA: 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm
• 10886705012480 - COR: 2024-08-20 Mitek COR Plunger 4mm, 5-25mm (Plus or Minus 10 Percent)