IMPEDE Embolization Plug - IMPEDE Embolization Plug, 5mm - SHAPE MEMORY MEDICAL INC

Duns Number:025984823

Device Description: IMPEDE Embolization Plug, 5mm

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More Product Details

Catalog Number

IMP-05

Brand Name

IMPEDE Embolization Plug

Version/Model Number

IMP-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181051,K181051

Product Code Details

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Device Record Status

Public Device Record Key

c18a958d-1f9f-4cef-80e6-0b47ebfd6526

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2020

Additional Identifiers

Package DI Number

10810041650006

Quantity per Package

1

Contains DI Package

00810041650009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SHAPE MEMORY MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12