AccessGUDID - DEVICE: DISTAL COVER (04953170071416)

GUDID

Device Identifier (DI) Information

Brand Name: DISTAL COVER
Version or Model: MAJ-411
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GV897000
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170071416
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: No description.

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?
64276	Endoscope patient protection cap, reusable	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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDT	Duodenoscope 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant

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: b3fcf782-b0ed-4d1c-99d4-63e66bc0aff5
Public Version Date: December 20, 2023
Public Version Number: 9
DI Record Publish Date: September 21, 2016