Catalog Number

52-2835

Brand Name

Stylus

Version/Model Number

52-2835

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K861947,K861947

Product Code

EMF

Product Code Name

KNIFE, SURGICAL

Public Device Record Key

eeafd3c6-79b4-4f96-aa15-e263634cda82

Public Version Date

April 06, 2021

Public Version Number

1

DI Record Publish Date

March 29, 2021

Package DI Number

10848782026125

Quantity per Package

6

Contains DI Package

00848782026128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box