AccessGUDID - DEVICE: OLYMPUS ENDOSCOPY KIT V (00810929044678)

GUDID

Device Identifier (DI) Information

Brand Name: OLYMPUS ENDOSCOPY KIT V
Version or Model: 345CKETE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 345CKETE
Company Name: Ruhof Corporation

Primary DI Number: 00810929044678
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082779828 *Terms of Use

Device Description: OLYMPUS ENDOSCOPY KIT V

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
61950	Endoscopy preparation kit	A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, 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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: cd3ed4d4-4eea-44c3-ae14-e1b328e2659b
Public Version Date: February 19, 2025
Public Version Number: 1
DI Record Publish Date: February 11, 2025