Catalog Number

MC214

Brand Name

MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER

Version/Model Number

MC214

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

K851834,K851834

Product Code

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Public Device Record Key

a37a4fd9-19a9-471e-8577-0e3f72800a41

Public Version Date

November 06, 2018

Public Version Number

1

DI Record Publish Date

October 06, 2018

Package DI Number

50884908028787

Quantity per Package

50

Contains DI Package

00884908028782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box