SonoSurg GE Tapered Sheath

GUDID 14953170183024

OLYMPUS MEDICAL SYSTEMS CORP.

Soft-tissue ultrasonic surgical system

• Primary Device ID: 14953170183024
• NIH Device Record Key: afd22db4-5267-4714-8453-5c85d91d26b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoSurg GE Tapered Sheath
• Version Model Number: T3330
• 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: 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)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	04953170183027 [Primary]
GS1	14953170183024 [Package]; Contains: 04953170183027; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050885

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

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

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

[14953170183024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-10-06

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170465949 - WATER CONTAINER: 2024-12-03
• 04953170465956 - WATER CONTAINER: 2024-12-03
• 04953170465963 - ENDOSCOPIC CO2 REGULATION UNIT: 2024-12-03
• 04953170465970 - EVIS EXERA III XENON LIGHT SOURCE: 2024-12-03
• 04953170454141 - VISERA S VIDEO SYSTEM CENTER: 2024-11-22
• 04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE: 2024-10-14
• 04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17