Single Use Mechanical Lithotriptor V

GUDID 14953170218344

Single Use Mechanical Lithotriptor V

OLYMPUS MEDICAL SYSTEMS CORP.

Lithotrite Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter Manual biliary stone fragmenter

• Primary Device ID: 14953170218344
• NIH Device Record Key: 875772b5-04ec-4953-83cf-07c568ca2c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Mechanical Lithotriptor V
• Version Model Number: BML-V232QR-26
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: true
• 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
• 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	04953170218347 [Primary]
GS1	14953170218344 [Package]; Contains: 04953170218347; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903529

FDA Product Code

• LQC: Lithotriptor, biliary mechanical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Single Use Mechanical Lithotriptor V]

• 14953170218429: Single Use Mechanical Lithotriptor V
• 14953170218412: BML-V437QR-30
• 14953170218399: Single Use Mechanical Lithotriptor V
• 14953170218382: BML-V237QR-30
• 14953170218368: Single Use Mechanical Lithotriptor V
• 14953170218344: Single Use Mechanical Lithotriptor V
• 14953170462617: BML-V437QR-30
• 14953170462594: BML-V237QR-30