Catalog Number

-

Brand Name

Sutter Pacific

Version/Model Number

FA13S10F0-00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

cf373e1b-5e26-4807-a057-186c1e80e62b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 30, 2017

Package DI Number

36939029816468

Quantity per Package

2

Contains DI Package

26939029816461

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box