Catalog Number

-

Brand Name

NA

Version/Model Number

12T7400

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

K041080,K041080

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

c52cfcd0-2cd7-4019-b7f9-86f9b7c9fe0e

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

38032248127402

Quantity per Package

2

Contains DI Package

08032248127401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case