Catalog Number

BGWI1902

Brand Name

Winged Guidewire Introducer Needle

Version/Model Number

BGWI1902

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

K974745,K974745

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

7e5e4876-ff71-411e-b734-ff7cb6c975bd

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

September 20, 2016

Package DI Number

20886333007411

Quantity per Package

25

Contains DI Package

00886333007417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box