Catalog Number

-

Brand Name

PLEATMAN SAC, Disposable Tissue Removal System

Version/Model Number

004942-901

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

K923945,K923945

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

e895ce0e-ad8c-4f04-8330-e14aa549f877

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

00821925009936

Quantity per Package

20

Contains DI Package

00821925037915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-