Catalog Number

86955

Brand Name

Nu Alloy Active Caps. Jar X 50 - 1 Spill

Version/Model Number

86955

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K140125

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Public Device Record Key

bea67e9f-0400-4d9a-9165-7651e88ddcc9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-