AUTOCLAVABLE TRANSDUCER

GUDID 04953170157134

MAJ-1215 AUTOCLAVABLE XDUCER FOR LUS-2

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasonic lithotripsy system transducer, reusable Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system

• Primary Device ID: 04953170157134
• NIH Device Record Key: 6c8e81f7-ae26-4c32-8432-0a112bb7e9d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTOCLAVABLE TRANSDUCER
• Version Model Number: MAJ-1215
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170157134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873367

FDA Product Code

• FEO: Lithotriptor, ultrasonic

Sterilization

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

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

[04953170157134]

Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

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