AccessGUDID - DEVICE: INTELLAGEN™ Remote Control Kit (04260166374094)

GUDID

Device Identifier (DI) Information

Brand Name: INTELLAGEN™ Remote Control Kit
Version or Model: 20403
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M004GEN100204030
Company Name: Stockert GmbH

Primary DI Number: 04260166374094
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:	Yes
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?
60784	Cardiac radio-frequency ablation system generator	An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
LPB	Cardiac Ablation Percutaneous Catheter

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
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 22 and 149 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Dry; Fragile, handle with care

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d312d76b-5580-40bb-bd2e-5437aa0ee087
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: September 01, 2024