AccessGUDID - DEVICE: Video Coupler (04953170028465)

GUDID

Device Identifier (DI) Information

Brand Name: Video Coupler
Version or Model: OLYMPUS MH-999E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5705130
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170028465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "MH-999E COUPLER OTV-S5 EYEPIEC"

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?
45804	Electrical mains power cable	An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery
EOQ	Bronchoscope (Flexible Or Rigid)
FAJ	Cystoscope And Accessories, Flexible/Rigid
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
KGE	Forceps, Biopsy, Electric
FDS	Gastroscope And Accessories, Flexible/Rigid
EOB	Nasopharyngoscope (Flexible Or Rigid)
FCL	Forceps, Biopsy, Non-Electric
FGB	Ureteroscope And Accessories, Flexible/Rigid
FGA	Kit, Nephroscope
FDI	Snare, Flexible
HET	Laparoscope, Gynecologic (And Accessories)
FDF	Colonoscope And Accessories, Flexible/Rigid
NWB	Endoscope, Accessories, Narrow Band Spectrum

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: c261bed8-2e65-4c0d-9bf4-eba2a1c8eef2
Public Version Date: December 25, 2023
Public Version Number: 10
DI Record Publish Date: September 21, 2016