Catalog Number

-

Brand Name

25GA Flexible Membrane Scraper

Version/Model Number

PD800.25SF

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"

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

-

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

b1f50231-028e-4d71-a9c3-e7a61b443690

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 06, 2016

Package DI Number

10632307000062

Quantity per Package

5

Contains DI Package

00632307000065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box