Catalog Number

MC217C

Brand Name

MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER

Version/Model Number

MC217C

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

34e60c35-a129-4d9d-9283-5f5dbf61b3d8

Public Version Date

November 06, 2018

Public Version Number

1

DI Record Publish Date

October 06, 2018

Package DI Number

50884908028817

Quantity per Package

50

Contains DI Package

00884908028812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box