CGuard Prime Carotid Stent System CND0940

GUDID 07290120281943

CGuard Prime Carotid Stent System 135cm, 9mmx40mm

INSPIRE M.D LTD

Mesh-sleeve carotid artery stent
Primary Device ID07290120281943
NIH Device Record Key78fff70c-cb19-44df-9b5c-8d4af2460160
Commercial Distribution StatusIn Commercial Distribution
Brand NameCGuard Prime Carotid Stent System
Version Model NumberCND0940
Catalog NumberCND0940
Company DUNS514477996
Company NameINSPIRE M.D LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS107290120281745 [Primary]
GS107290120281943 [Package]
Contains: 07290120281745
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIMStent, Carotid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

On-Brand Devices [CGuard Prime Carotid Stent System]

07290120281981CGuard Prime Carotid Stent System 135cm,10mmx40mm
07290120281974CGuard Prime Carotid Stent System 135cm,10mmx30mm
07290120281943CGuard Prime Carotid Stent System 135cm, 9mmx40mm
07290120281936CGuard Prime Carotid Stent System 135cm, 9mmx30mm
07290120281905CGuard Prime Carotid Stent System 135cm, 8mmx40mm
07290120281899CGuard Prime Carotid Stent System 135cm, 8mmx30mm

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