Catalog Number

4412A

Brand Name

N/A

Version/Model Number

4412A

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)

Yes

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

db9746fe-22f6-4a86-95b6-1ed3470593b7

Public Version Date

April 02, 2019

Public Version Number

1

DI Record Publish Date

March 25, 2019

Package DI Number

50885403450585

Quantity per Package

50

Contains DI Package

20885403450584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case