Catalog Number

KW-1000-080

Brand Name

HBS-Guide Wire ø 1.0x80mm

Version/Model Number

KW-1000-080

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

bb32905c-8590-413a-be7b-d081b906ba0a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 05, 2016

Package DI Number

EMAHKW10000801

Quantity per Package

1

Contains DI Package

EMAHKW10000800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-