Catalog Number

CCA01

Brand Name

Rospital Productos Medicos

Version/Model Number

CCA01

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

K082815,K082815,K082815

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

37a730ee-6f25-4560-8121-0d2ee60f4ce5

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

June 13, 2020

Package DI Number

10812460027674

Quantity per Package

10

Contains DI Package

00812460027677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER