Catalog Number

9160

Brand Name

3M™

Version/Model Number

9160

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"

Yes

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

K974553,K974553,K974553

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

84755549-cf17-42c1-8c6a-af696f1b35fb

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

November 01, 2016

Package DI Number

50707387462586

Quantity per Package

2

Contains DI Package

10707387462588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX