AccessGUDID - DEVICE: Olympus (15019778008486)

GUDID

Device Identifier (DI) Information

Brand Name: Olympus
Version or Model: WM-NP3 Mobile Workstation US 15A UR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K10037159
Company Name: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED

Primary DI Number: 15019778008486
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217061423 *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?
35124	Medical device integration rack	A device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)

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: 93b9048f-b6e9-4ac8-96e0-972ab3143749
Public Version Date: June 29, 2023
Public Version Number: 1
DI Record Publish Date: June 21, 2023