Catalog Number

5513E

Brand Name

N/A

Version/Model Number

5513E

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

-

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

58c6ee8d-5cf6-4a7b-9d91-2b5465224c80

Public Version Date

April 02, 2019

Public Version Number

1

DI Record Publish Date

March 25, 2019

Package DI Number

50885403473171

Quantity per Package

20

Contains DI Package

20885403473170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case