Catalog Number

-

Brand Name

VACURETTE STRAIGHT 11MM 10/PKG

Version/Model Number

21415

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

K030935,K030935

Product Code

HHI

Product Code Name

SYSTEM, ABORTION, VACUUM

Public Device Record Key

eef3ab1f-e6e1-4dc9-b9d1-4dbd7467d65a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

00821925000988

Quantity per Package

10

Contains DI Package

00821925037502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-