Ultramatrix USBOR

GUDID 10724995180772

Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.

US Endoscopy

Ultrasound endoscope balloon, synthetic polymer

• Primary Device ID: 10724995180772
• NIH Device Record Key: a57ab119-3fef-4a9c-a7c6-3d4f73c75b47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultramatrix
• Version Model Number: USBOR
• Catalog Number: USBOR
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995180775 [Primary]
GS1	00816765014332 [Previous]
GS1	10724995180772 [Package]; Contains: 00724995180775; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180731

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-10
• Device Publish Date: 2020-04-02

On-Brand Devices [Ultramatrix]

• 10816765014339: Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications usi
• 10816765014322: The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications using
• 10724995180772: Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications usi
• 10724995180765: The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications using