Catalog Number

-

Brand Name

N/A

Version/Model Number

DMC3B

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

-

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

d49622ec-3237-4d14-af24-1d65aa33cdb3

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

50884908144678

Quantity per Package

5

Contains DI Package

00884908144673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX