AccessGUDID - DEVICE: DIGITAL MEDICAL SCOPE (04987669101056)

GUDID

Device Identifier (DI) Information

Brand Name: DIGITAL MEDICAL SCOPE
Version or Model: DS-10EA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in the market. The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body.

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Endoscope camera adaptor	A 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. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
FTT	Camera, Still, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: bbabea29-15d8-4593-aa04-a1f4701bb59e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 31, 2017