Oracle 00711893

GUDID 10724995184121

The Oracle EUS latex 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, Hevea-latex

• Primary Device ID: 10724995184121
• NIH Device Record Key: 5d490264-0a08-4a95-90c6-71b1756134e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oracle
• Version Model Number: 00711893
• Catalog Number: 00711893
• 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: 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)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

• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• 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	00724995184124 [Primary]
GS1	00816765013458 [Previous]
GS1	10724995184121 [Package]; Contains: 00724995184124; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163492

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

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 [Oracle]

• 10816765013455: The Oracle EUS latex balloon is intended to be used in endoscopic procedures that utilize a ball
• 10816765013448: The Oracle EUS latex balloon- Olympus radial is used with Olympus radial endoscopes endoscopic p
• 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