Oracle 00711891

GUDID 10816765011932

The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.

US Endoscopy

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

• Primary Device ID: 10816765011932
• NIH Device Record Key: 98d71bc3-06ac-45d3-9598-be2d7ec130e0
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Oracle
• Version Model Number: 00711891
• Catalog Number: 00711891
• 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	00816765011935 [Primary]
GS1	10816765011932 [Package]; Contains: 00816765011935; Package: Box [20 Units]; Discontinued: 2020-03-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111028

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-17

On-Brand Devices [Oracle]

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• 10816765011932: The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in
• 10724995184121: The Oracle EUS latex balloon is intended to be used in endoscopic procedures that utilize a ball
• 10724995184114: The Oracle EUS latex balloon- Olympus radial is used with Olympus radial endoscopes endoscopic p
• 10724995184107: The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in