Catalog Number

-

Brand Name

ANA 70 Capsules 2 Spill 50 count

Version/Model Number

1113100

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

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

K002811

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Public Device Record Key

f50dceba-9319-4dc4-a0e7-20574ea198dd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-