Catalog Number

ML7003

Brand Name

ML7003

Version/Model Number

ML7003

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

K962661,K962661

Product Code

HNY

Product Code Name

Cystotome

Public Device Record Key

bfdc82b5-53e4-468c-a158-675e9d09e0c5

Public Version Date

August 20, 2020

Public Version Number

1

DI Record Publish Date

August 12, 2020

Package DI Number

10850724001015

Quantity per Package

10

Contains DI Package

00850724001018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box