AccessGUDID - DEVICE: SINGLE USE DISTAL COVER (04953170403019)

GUDID

Device Identifier (DI) Information

Brand Name: SINGLE USE DISTAL COVER
Version or Model: MAJ-2315
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N5786100
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170403019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: SINGLE USE DISTAL COVER MAJ-2315

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?
64277	Endoscope patient protection cap, single-use	An invasive device, typically in the form of a detachable cap, designed to cover the exposed mechanical components at the distal end of an endoscope (e.g., duodenoscope) during an endoscopic procedure to protect the patient from injury. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWB	Endoscope, accessories, narrow band spectrum
FDT	Duodenoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193182	000

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
No Device Sizes

Device Record Status

Public Device Record Key: f6f47962-8b03-41c7-8f86-8065d5e205c9
Public Version Date: April 22, 2024
Public Version Number: 7
DI Record Publish Date: January 27, 2020