Catalog Number

-

Brand Name

Quattro Guidewire 0.035" (0.89mm) x 150cm Dual Flex, Dual Floppy Tips

Version/Model Number

50BX

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

33f751a5-94be-4b33-a23b-1d1b0b7acb4c

Public Version Date

October 12, 2018

Public Version Number

1

DI Record Publish Date

September 11, 2018

Package DI Number

00821925011007

Quantity per Package

5

Contains DI Package

00821925031487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-