AccessGUDID - DEVICE: colonic FTRD prOVE Cap (04260206311157)

GUDID

Device Identifier (DI) Information

Brand Name: colonic FTRD prOVE Cap
Version or Model: FTRD 14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200.71
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206311157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use
Previous DI: 04260206310624

Device Description: FTRD application cap for verification of possible application of the colonic FTRD (accessability and ability to pull lesion into the cap).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
64092	Endoscopic electrosurgical biopsy/resection cap trial	A copy of the distal endoscopic cap used in a full-thickness endoscopic electrosurgical biopsy/resection kit, intended to be used to determine if the treatment cap is of the correct size to reach the lesion and for the lesion to be pulled into the cap in order to be resected. It is in the form of a clear plastic tube designed to be placed onto the distal end of an endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEI	Instrument, Special Lens, For Endoscope

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 11.5-13.2 mm

Device Record Status

Public Device Record Key: 8c2c5887-a2d9-4dad-a574-b4ffae4d8ff4
Public Version Date: October 31, 2019
Public Version Number: 2
DI Record Publish Date: March 08, 2019