Catalog Number

-

Brand Name

E.M. Adams Company

Version/Model Number

14-3390-1

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

50c611f3-1b88-4499-9cc1-29b3cedd8c4a

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2022

Package DI Number

50840200325313

Quantity per Package

100

Contains DI Package

10840200325322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE