OTSG Xcavator

Basic Information

• Brand Name: OTSG Xcavator
• Primary DI: 04260206311317
• Version / Model: Xcavator
• Catalog Number: 200.15
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-02
• Public Version: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: fa9fe366-4bce-4524-b353-d26198f35e17

Device Description

The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that can grasp large volume of tissue or foreign bodies • for use with standard flexible endoscopes • allows for the use of additional endoscopic instruments or a guide wire through the working channel of the endoscope • flexible shaft • includes an endoscope sleeve and appropriate adhesive tapes

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58841	Endoscope tissue removal cap, single-use	A plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260206311300	GS1	Folding box	2	In Commercial Distribution
Primary	04260206311317	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			endoscope diameter 9.5 to 10.5 mm
Device Size Text, specify			working length 165 cm