BALLOON3

GUDID 04953170360442

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasound endoscope balloon, Hevea-latex

• Primary Device ID: 04953170360442
• NIH Device Record Key: d6aa84fd-ee64-4bbc-a653-902ccf4b1bc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALLOON3
• Version Model Number: MAJ-249
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 20
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170360442 [Primary]
GS1	84953170360448 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010591

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

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 [BALLOON3]

• 04953170360442: MAJ-249
• 04953170360435: MAJ-236
• 04953170360428: MAJ-233
• 14953170058889: MAJ-249
• 14953170058858: MAJ-236
• 14953170058780: MAJ-233