Catalog Number

PL430R

Brand Name

AESCULAP

Version/Model Number

PL430R

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

-

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

KNA

Product Code Name

INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Public Device Record Key

fe4deb56-235a-4daf-9096-4fcfabffb39d

Public Version Date

January 15, 2020

Public Version Number

3

DI Record Publish Date

May 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-