AdvanCE 00711144

GUDID 10724995183605

The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm - 26.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

US Endoscopy

Video capsule endoscopy system capsule introducer Video capsule endoscopy system capsule introducer Video capsule endoscopy system capsule introducer Video capsule endoscopy system capsule introducer Video capsule endoscopy system capsule introducer

• Primary Device ID: 10724995183605
• NIH Device Record Key: 4db4d90d-b32b-4f9c-be74-42a4a32cbb71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdvanCE
• Version Model Number: 00711144
• Catalog Number: 00711144
• 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

Device Dimensions

• Length: 180 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 180 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 180 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 180 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 180 Centimeter

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	00724995183608 [Primary]
GS1	00816765011188 [Previous]
GS1	10724995183605 [Package]; Contains: 00724995183608; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163495

FDA Product Code

• NEZ: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

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: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [AdvanCE]

• 10816765011185: The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indic
• 10724995183605: The disposable AdvanCE capsule endoscope delivery device is a 2.5mm single sheathed device indic