AccessGUDID - DEVICE: OTSG Xcavator (04260206311317)

GUDID

Device Identifier (DI) Information

Brand Name: OTSG Xcavator
Version or Model: Xcavator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200.15
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206311317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	Surgical Instruments, G-U, Manual (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: fa9fe366-4bce-4524-b353-d26198f35e17
Public Version Date: April 07, 2021
Public Version Number: 2
DI Record Publish Date: November 02, 2020