AccessGUDID - DEVICE: SB Soft Hood /Undercut type (04545499068910)

GUDID

Device Identifier (DI) Information

Brand Name: SB Soft Hood /Undercut type
Version or Model: MD-47971
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SB-KAWASUMI LABORATORIES, INC.

Primary DI Number: 04545499068910
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690625850 *Terms of Use

Device Description: The Product is a transparent distal attachment applied to the tip of the endoscope. It is used in ESD procedures. This Product is used for maintaining visualization during the dissection phase of the procedure. This Product contains drainage side hole that allows egress of water and blood. This Product is disposable and in a variety of diameters that correspond to different endoscope sizes.

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":	No
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?
61497	Endoscope hood	A sterile, Hevea-latex, bell-shaped device designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of a foreign body. The device everts to create a dome around the (sharp) foreign object to protect the wall of the viscus as the endoscope/foreign body is extracted. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDS	Gastroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Outer Diameter: 16.2 Millimeter

Device Record Status

Public Device Record Key: 01ceb8bc-97b1-45de-94a2-ddc70237b44b
Public Version Date: May 30, 2022
Public Version Number: 3
DI Record Publish Date: September 30, 2018