AccessGUDID - DEVICE: Ilesto 7 DR-T DF4 US (04035479125202)

GUDID

Device Identifier (DI) Information

Brand Name: Ilesto 7 DR-T DF4 US
Version or Model: 383564
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 383564
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479125202
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *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:	Yes
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?
37265	Dual-chamber implantable defibrillator	A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). It is implanted in a pouch beneath the skin of the patient's chest or abdomen and intended to be used with leads that are positioned inside the right atrium and right ventricle to monitor the ECG and to automatically deliver the electrical impulse; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRM	DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 41 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3aa6a438-19a5-44e9-966b-e2f6a4b69c82
Public Version Date: December 03, 2024
Public Version Number: 7
DI Record Publish Date: August 06, 2014