AccessGUDID - DEVICE: Video Adapter (04953170023804)

GUDID

Device Identifier (DI) Information

Brand Name: Video Adapter
Version or Model: OLYMPUS AR-T12E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5391830
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170023804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: AR-T12E SINGLE PIECE E ADAPTER 1.2X OTV-

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?
36292	Endoscope camera adaptor	An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971416	000

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: 4f7010d8-0b13-43ac-a5b5-ddf0822e4271
Public Version Date: April 22, 2024
Public Version Number: 10
DI Record Publish Date: September 21, 2016