IMPEDE Embolization Plug IMP-07

GUDID 10810041650013

IMPEDE Embolization Plug, 7mm

SHAPE MEMORY MEDICAL INC

Vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use Extraluminal vascular occluder, single-use
Primary Device ID10810041650013
NIH Device Record Key75bbb7b8-14f7-4162-b8a4-06b0459003a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPEDE Embolization Plug
Version Model NumberIMP-07
Catalog NumberIMP-07
Company DUNS025984823
Company NameSHAPE MEMORY MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100810041650016 [Primary]
GS110810041650013 [Package]
Contains: 00810041650016
Package: [1 Units]
In Commercial Distribution
HIBCCB054IMP071 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

On-Brand Devices [IMPEDE Embolization Plug]

B054IMP101IMPEDE Embolization Plug 10mm
B054IMP071IMPEDE Embolization Plug 7mm
B054IMP051IMPEDE Embolization Plug 5mm
10810041650020IMPEDE Embolization Plug, 10mm
10810041650013IMPEDE Embolization Plug, 7mm
10810041650006IMPEDE Embolization Plug, 5mm

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