Balloon Applicator

GUDID 04953170061912

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasound endoscope balloon, Hevea-latex

• Primary Device ID: 04953170061912
• NIH Device Record Key: b7f1cd60-664e-4c99-b4f6-b93c9ba8cb88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon Applicator
• Version Model Number: MAJ-675
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170061912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093395

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

Sterilization

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

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

[04953170061912]

High-level Disinfectant;Ethylene Oxide

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

On-Brand Devices [Balloon Applicator]

• 04953170368547: MAJ-564
• 04953170175626: MAJ-1352
• 04953170065262: "MD-688 Balloon applicator for JF-UM20"
• 04953170062865: "6842600 OLA MAJ-864 RADIAL SCOPE BALLOON"
• 04953170061912: MAJ-675
• 04953170061899: 5792300 OLA MAJ-564 BALLOON APPLICATOR F
• 04953170055553: "MH-526 Balloon applicator for MH-908"