Catalog Number

CW500101

Brand Name

Rospital Productos Medicos

Version/Model Number

CW500101

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"

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

EFN

Product Code Name

Cotton, Roll

Public Device Record Key

75d0a3c1-23df-4506-8859-45d293f21fae

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

10812460020828

Quantity per Package

40

Contains DI Package

00812460020821

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE