Catalog Number

SMS215/F

Brand Name

Futura®

Version/Model Number

10884450121877

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)

-

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

7a67e359-ae36-4b6f-a8b4-ae16e13895a3

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

May 02, 2018

Package DI Number

20884450121874

Quantity per Package

2

Contains DI Package

10884450121877

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-