Catalog Number

004CB

Brand Name

CMI

Version/Model Number

Vacuum Delivery Cup 60mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K881306,K881306

Product Code

HDB

Product Code Name

Extractor, Vacuum, Fetal

Public Device Record Key

1b3d69d0-2944-4006-a059-3e685b0ec56b

Public Version Date

December 17, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

H671004CB1

Quantity per Package

10

Contains DI Package

H671004CB0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box