Catalog Number

DFSX

Brand Name

N/AN/A

Version/Model Number

DFSX

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

f0c141ac-ef42-416f-8620-901366d0dbe0

Public Version Date

August 19, 2019

Public Version Number

1

DI Record Publish Date

August 10, 2019

Package DI Number

50884908145705

Quantity per Package

5

Contains DI Package

00884908145700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box