Paradym RF

GUDID 08031527012254

MICROPORT CRM SRL

Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator
Primary Device ID08031527012254
NIH Device Record Keya283af5f-2c31-4eb6-a7cc-15b16c4ae525
Commercial Distribution StatusIn Commercial Distribution
Brand NameParadym RF
Version Model NumberDR 9550
Company DUNS438860859
Company NameMICROPORT CRM SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108031527012254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRMDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-20
Device Publish Date2014-09-05

On-Brand Devices [Paradym RF]

08031527012278CRT-D 9750
08031527012261VR 9250
08031527012254DR 9550

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.