Intensia

GUDID 08031527012827

MICROPORT CRM SRL

Dual-chamber implantable defibrillator
Primary Device ID08031527012827
NIH Device Record Key6b63a507-40e1-4ea1-b16f-661942ee0672
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntensia
Version Model NumberDR 154
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
GS108031527012827 [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 Date2015-02-20

On-Brand Devices [Intensia]

08031527012834VR 124
08031527012827DR 154
08031527012810CRT-D 174

Trademark Results [Intensia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTENSIA
INTENSIA
78189639 2802380 Live/Registered
Proven Winners North America LLC
2002-11-27
INTENSIA
INTENSIA
74179725 1842420 Dead/Cancelled
SOMAR CORPORATION
1991-06-25

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