Catalog Number

0377-030-400

Brand Name

NA

Version/Model Number

0377030400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 23, 2022

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

-

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

02a52295-57be-4a9e-8abb-e38642bb4cf0

Public Version Date

October 25, 2022

Public Version Number

2

DI Record Publish Date

August 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-