BALLOON APPLICATOR

GUDID 04953170175626

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasound endoscope balloon, Hevea-latex Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted Surgical instrument assist arm system, manually-adjusted

• Primary Device ID: 04953170175626
• NIH Device Record Key: 1b0dea2d-324a-4b5e-b175-6d0469bde854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALLOON APPLICATOR
• Version Model Number: MAJ-1352
• 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: 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
• 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	04953170175626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042140

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04953170175626]

High-level Disinfectant;Ethylene Oxide;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: 2017-10-12

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• 04953170061912: MAJ-675
• 04953170061899: 5792300 OLA MAJ-564 BALLOON APPLICATOR F
• 04953170055553: "MH-526 Balloon applicator for MH-908"