Catalog Number

CP01786A

Brand Name

Guidewire Bowl

Version/Model Number

0M-CP01786A

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

FMH

Product Code Name

Container, Specimen, Sterile

Public Device Record Key

05fba8cd-e824-42f8-829d-6423e0f4ec28

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Package DI Number

20886333206692

Quantity per Package

20

Contains DI Package

00886333206698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box