Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

14-3591-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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)

Yes

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

K812133,K812133,K812133

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

c2189236-1286-4c94-9bad-397fa3ffb3ce

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

December 31, 2019

Package DI Number

38100013402464

Quantity per Package

20

Contains DI Package

18100013402453

Package Discontinue Date

February 28, 2021

Package Status

Not in Commercial Distribution

Package Type

BX