Catalog Number

-

Brand Name

MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER

Version/Model Number

MC224

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 14, 2018

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

00839ad7-8d4e-4539-a05f-04826c08b9f4

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

January 13, 2018

Package DI Number

50884908105280

Quantity per Package

1

Contains DI Package

00884908105285

Package Discontinue Date

November 14, 2018

Package Status

Not in Commercial Distribution

Package Type

box