AccessGUDID - DEVICE: n.a. (04048551067642)

GUDID

Device Identifier (DI) Information

Brand Name: n.a.
Version or Model: 26331077
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551067642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: SCB Upgrade Kit for Endomat

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
Endoscopic video image processor	A mains electricity (AC-powered) device designed to receive the electronic signals sent from a video endoscope or endoscopic video camera for the purpose of processing them. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process, and also the images can be recorded on a video recorder or stored on computerized media. Hard copy pictures can also be produced through the use of other devices.

GMDN Preferred Term Name

GMDN Definition

Endoscopic video image processor

A mains electricity (AC-powered) device designed to receive the electronic signals sent from a video endoscope or endoscopic video camera for the purpose of processing them. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process, and also the images can be recorded on a video recorder or stored on computerized media. Hard copy pictures can also be produced through the use of other devices.

FDA Product Code

[?]

Product Code	Product Code Name
OCX	endoscopic irrigation/suction system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031457	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: 464a0f1a-eb10-470f-a540-e61fff1adbbf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016