AccessGUDID - DEVICE: IMAGE1 CONNECT (04048551356586)

GUDID

View all sections | Close all sections

Device Identifier (DI) Information

Brand Name: IMAGE1 CONNECT
Version or Model: TC200US
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551356586
Issuing Agency: GS1
Device Count: 1

Device Description: CCU,MODULAR,IMAGE 1 CONNECT,US

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
FET	Endoscopic video imaging system/component, gastroenterology-urology

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: IMAGE1 CONNECT (04048551356586)