Catalog Number

RZPTU01

Brand Name

AMSafe® Prep Razor

Version/Model Number

1

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

LWK

Product Code Name

Razor, Surgical

Public Device Record Key

08731935-e148-4f27-af74-5fc9234cc7cc

Public Version Date

July 05, 2018

Public Version Number

1

DI Record Publish Date

June 04, 2018

Package DI Number

40704411008072

Quantity per Package

10

Contains DI Package

10704411008071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case