AdvanCE

Basic Information

• Brand Name: AdvanCE
• Primary DI: 00724995183608
• Version / Model: 00711144
• Catalog Number: 00711144
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-19
• Public Version: 2
• Public Version Date: 2020-11-10
• Public Version Status: Update
• Public Device Record Key: 4db4d90d-b32b-4f9c-be74-42a4a32cbb71

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEZ	SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE	Gastroenterology, Urology	876.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62153	Video capsule endoscopy system capsule introducer	A non-sterile hand-held device intended to be introduced through a gastroscope to deliver a video capsule to the stomach/duodenum for the internal visualization and examination of the gastrointestinal (GI) tract. It is typically used in patients who are unable to swallow the video capsule or pass it beyond the pylorus in sufficient time. It is in the form of a shaft-like device with ring handles to control the release of the distally-mounted video capsule. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995183605	GS1	Case	3	In Commercial Distribution
Primary	00724995183608	GS1
Previous	00816765011188	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.5	Millimeter
Length	180	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry