Catalog Number

SMARTCLIP-PINK-10

Brand Name

SmartClip

Version/Model Number

SMARTCLIP-PINK-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 13, 2022

Issuing Agency

In GS1

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

K180640,K180640

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

e9e11b23-84d6-485c-bcb8-7c5b0bdec25e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-