AccessGUDID - DEVICE: Connection Cable Remote Control / RF-Generator (04260166370515)

GUDID

Device Identifier (DI) Information

Brand Name: Connection Cable Remote Control / RF-Generator
Version or Model: S7021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Stockert GmbH

Primary DI Number: 04260166370515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327536314 *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

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

GMDN Preferred Term Name	GMDN Definition
Electrical catheter connection cable, reusable	An insulated electrical conductor designed to provide an electrical connection between an electrical catheter (e.g., an electrophysiological diagnostic catheter or ablation catheter) and an electrically-powered parent device (e.g., generator, analyser). Its length may also allow the catheter to remain in the sterile field. This device will be made of robust materials with metal connectors, e.g., gold (Au) plated electrical connecting pins and sockets, that ensure continued reliability each time it is reused. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Electrical catheter connection cable, reusable

An insulated electrical conductor designed to provide an electrical connection between an electrical catheter (e.g., an electrophysiological diagnostic catheter or ablation catheter) and an electrically-powered parent device (e.g., generator, analyser). Its length may also allow the catheter to remain in the sterile field. This device will be made of robust materials with metal connectors, e.g., gold (Au) plated electrical connecting pins and sockets, that ensure continued reliability each time it is reused. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Premarket Submission

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

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: 9c66cadf-b86a-46e8-ad50-818fa3e560f1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2014