Catalog Number

-

Brand Name

Anzen Safety Scalpel

Version/Model Number

AZ15

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GES

Product Code Name

Blade, Scalpel

Public Device Record Key

67f08a29-c890-4558-bba1-70d9da83f96d

Public Version Date

November 15, 2021

Public Version Number

6

DI Record Publish Date

January 02, 2017

Package DI Number

58886354702473

Quantity per Package

6

Contains DI Package

48886354702476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case