AccessGUDID - DEVICE: 12G-SDI cable (04953170415623)

GUDID

Device Identifier (DI) Information

Brand Name: 12G-SDI cable
Version or Model: MAJ-2428
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N6013400
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170415623
Issuing Agency: GS1
Commercial Distribution End Date: July 09, 2024
Device Count: 1
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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (Flexible Or Rigid)
EOB	Nasopharyngoscope (Flexible Or Rigid)
FDF	Colonoscope And Accessories, Flexible/Rigid
FDS	Gastroscope And Accessories, Flexible/Rigid
NWB	Endoscope, Accessories, Narrow Band Spectrum
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
NTN	Led Light Source

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222584	000
K222861	000

Device Exempt from Premarket Submission: No 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: ab42ff48-a2d3-46e7-93f7-6bacc7ebac38
Public Version Date: July 10, 2024
Public Version Number: 4
DI Record Publish Date: July 04, 2023