Catalog Number

-

Brand Name

Fraxis Duo 25Pin Needle Tip

Version/Model Number

MTR-AC-25

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

K160312,K160312

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

64e63122-d9ec-429c-87af-c302b63767f5

Public Version Date

January 23, 2019

Public Version Number

4

DI Record Publish Date

December 16, 2016

Package DI Number

18800023200079

Quantity per Package

10

Contains DI Package

08800023200058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-