Micro Plug Set - Micro Plug Set - 3mm - KA MEDICAL LLC

Duns Number:079456139

Device Description: Micro Plug Set - 3mm

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More Product Details

Catalog Number

90000

Brand Name

Micro Plug Set

Version/Model Number

90000

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

K182944

Product Code Details

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Device Record Status

Public Device Record Key

7ab1da43-643b-476b-9d69-e4b289cf4a1e

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

April 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KA MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4