Catalog Number

-

Brand Name

SUREGLIDE Guidewire 0.038" (0.97mm) x 150cm Regular Body, 3cm Straigh

Version/Model Number

38BX

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

-

Product Code

EYA

Product Code Name

STYLET, URETERAL

Public Device Record Key

293d2f75-ddd3-4d69-9482-96819781a8d1

Public Version Date

October 12, 2018

Public Version Number

1

DI Record Publish Date

September 11, 2018

Package DI Number

00821925009967

Quantity per Package

5

Contains DI Package

00821925006034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-