IMPEDE-FX Embolization Plug

Primary DI
10810041650051
Brand
IMPEDE-FX Embolization Plug
Company
SHAPE MEMORY MEDICAL INC
Model
IMP-FX-12
Catalog number
IMP-FX-12
Device description
IMPEDE-FX Embolization Plug, 12mm
Published
2020-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182390000IMPEDE-FX Embolization PlugShape Memory Medical2019-05-23KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041650051PackageGS11In Commercial Distribution
B054IMPFX121PreviousHIBCC0
00810041650054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004165005110810041650051
00810041650054008100416500548100416500540810041650054

GMDN Terms#

Term, Definition table
TermDefinition
Vascular occluder, single-useA device intended to be used to mechanically stop or interrupt the flow of blood in veins or arteries temporarily during vascular surgery and emergency trauma surgery. It is typically designed with a ring having a small portion left open so that it can be slipped over the blood vessel to be occluded, or it can have semicircular pivoted arms that can be opened and placed over the vessel with a latch to lock the arms once in place. The inner surface of this ring is lined with a soft-plastic balloon, or pair of balloons, inflated via a connecting tube using a standard syringe. This device facilitates occlusion with minimal trauma to the wall of the blood vessel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025984823
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810041650006IMPEDE Embolization PlugIMP-05IMP-052020-04-02
10810041650013IMPEDE Embolization PlugIMP-07IMP-072020-04-02
10810041650020IMPEDE Embolization PlugIMP-10IMP-102020-04-02
10810041650037IMPEDE-FX Embolization PlugIMP-FX-06IMP-FX-062020-04-02
10810041650044IMPEDE-FX Embolization PlugIMP-FX-08IMP-FX-082020-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857798005093Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005109Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005123Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005130Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
10857798005147Nitinol Enhanced DeviceEmbolization Inc.KRD2026-02-12
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