Catalog Number

-

Brand Name

Sunmed

Version/Model Number

7-6513-10

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

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

4ad19154-356d-4a95-95df-c689342ca4d5

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

October 05, 2016

Package DI Number

20889483038007

Quantity per Package

10

Contains DI Package

10889483038000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box