Ultramatrix USBOL

GUDID 10816765014322

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

US Endoscopy

Ultrasound endoscope balloon, synthetic polymer Ultrasound endoscope balloon, synthetic polymer Ultrasound endoscope balloon, synthetic polymer

• Primary Device ID: 10816765014322
• NIH Device Record Key: b5b0f136-b296-4bc1-9bc3-ce535da87f3a
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ultramatrix
• Version Model Number: USBOL
• Catalog Number: USBOL
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765014325 [Primary]
GS1	00864390000336 [Previous]
GS1	10816765014322 [Package]; Contains: 00816765014325; Package: Case [20 Units]; Discontinued: 2020-03-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180731

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic
• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2018-08-23

On-Brand Devices [Ultramatrix]

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• 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