Catalog Number

-

Brand Name

Obstetrical Kit

Version/Model Number

4902

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KNA

Product Code Name

Instrument, Manual, Specialized Obstetric-Gynecologic

Public Device Record Key

42d2dd1f-71af-4f2b-a637-aa94ee332ad5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

00616784490236

Quantity per Package

10

Contains DI Package

00616784490229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-