Catalog Number

DBF-2.4SN-160SP-S

Brand Name

Captura

Version/Model Number

G56128

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

PTS

Product Code Name

Endoscopic grasping/cutting instrument, non-powered, exempt

Public Device Record Key

0138e2d9-af47-43df-ae62-b142689a2fd3

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 05, 2018

Package DI Number

10827002561288

Quantity per Package

10

Contains DI Package

00827002561281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX