Catalog Number

-

Brand Name

NC50000T

Version/Model Number

NC50000T

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

-

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

112a2cd0-8efe-4c90-ba50-7c70d133c075

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 19, 2018

Package DI Number

10816336020974

Quantity per Package

20

Contains DI Package

10816336020349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-