Catalog Number

106-1501

Brand Name

SCOTT'S SELECT ALLOY 50/jar 1 SPILL

Version/Model Number

106-1501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140125,K140125

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Public Device Record Key

4f101a5a-57a1-4f74-a02d-9731e9aa859a

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

May 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-