Catalog Number

0860/A

Brand Name

DFINE®

Version/Model Number

00884450296110

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

K091310,K091310

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

3e816937-eecb-4b6b-8c48-e6aceba7b5e6

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 16, 2017

Package DI Number

10884450296117

Quantity per Package

75

Contains DI Package

00884450296110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-