Catalog Number

5514A

Brand Name

N/A

Version/Model Number

5514A

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

211dbabe-f939-4179-95d3-6424de8aae22

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

March 25, 2019

Package DI Number

20885403473200

Quantity per Package

1

Contains DI Package

10885403473203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box