Catalog Number

6770-200-015

Brand Name

Spetzler-Malis

Version/Model Number

6770-200-015

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

-

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

43c4ba35-7f0c-4cc1-b010-95ad406ccfb8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 03, 2017

Package DI Number

37613327300353

Quantity per Package

5

Contains DI Package

07613327300352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack