BALLOON SHEATH

GUDID 14953170365123

This model includes one of connector section and five of insertion sections. The connector section is reusable and requires autoclave sterilization pr

OLYMPUS MEDICAL SYSTEMS CORP.

Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex Ultrasound endoscope balloon, Hevea-latex

• Primary Device ID: 14953170365123
• NIH Device Record Key: e145a256-d84a-4e56-a76a-cb1810ec62f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BALLOON SHEATH
• Version Model Number: MH-246R
• 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: 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
• 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	04953170365126 [Primary]
GS1	14953170365123 [Package]; Contains: 04953170365126; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961048

FDA Product Code

• FED: endoscopic access overtube, 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 [BALLOON SHEATH]

• 14953170365130: MH-246R
• 14953170365123: This model includes one of connector section and five of insertion sections. The connector secti
• 14953170365116: MAJ-643R
• 14953170061872: MAJ-643R
• 14953170059077: MH-246R
• 14953170058995: MH-246R
• 14953170463515: MH-246R
• 14953170463508: MH-246R