Oracle 00711893

GUDID 10816765013455

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: 10816765013455
• NIH Device Record Key: c755d6d9-73be-4c73-83b8-93106b6ecae4
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not 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
• 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
• 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
• 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
• 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 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765013458 [Primary]
GS1	10816765013455 [Package]; Contains: 00816765013458; Package: Box [20 Units]; Discontinued: 2020-03-31; Not 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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-31
• Device Publish Date: 2017-06-30

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