Catalog Number

HDBF-2.4-230-S

Brand Name

Captura

Version/Model Number

G31583

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

KGE

Product Code Name

FORCEPS, BIOPSY, ELECTRIC

Public Device Record Key

beec7ad8-f63b-46c8-8670-62197d0509dd

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10827002315836

Quantity per Package

5

Contains DI Package

00827002315839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-