Catalog Number

MDA

Brand Name

Meatal Dilator Adult

Version/Model Number

MDA

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

KOE

Product Code Name

Dilator, Urethral

Public Device Record Key

f8c69e9e-0b73-4492-863f-4c350eb45bc1

Public Version Date

September 25, 2020

Public Version Number

1

DI Record Publish Date

September 17, 2020

Package DI Number

10812261012985

Quantity per Package

10

Contains DI Package

00812261012988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-