Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

14-3343-1

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)

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

1c6d476e-496d-40ef-996f-20470df87832

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

50840200301805

Quantity per Package

100

Contains DI Package

10840200301814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case