AccessGUDID - DEVICE: Distal Hood (04953170063886)

GUDID

Device Identifier (DI) Information

Brand Name: Distal Hood
Version or Model: MB-145
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170063886
Issuing Agency: GS1
Commercial Distribution End Date: August 12, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "MB-145 DISTAL HOOD SHORT F/CF- CF-P10L/I"

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:	No
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?
65403	Endoscope observation cap, reusable	A short, light-penetrating tube designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap and is available in a range of diameters to accommodate common endoscope diameters. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FET	Endoscopic video imaging system/component, gastroenterology-urology

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0bc743d-163c-4cea-a9c7-ebb383c9e6d9
Public Version Date: April 01, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2016