Catalog Number

00216

Brand Name

Olympus

Version/Model Number

00216

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 15, 2021

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

-

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

K950719

Product Code

EZO

Product Code Name

Urethrotome

Public Device Record Key

eaa51fb4-3d67-484b-81e2-f0870afba0ca

Public Version Date

July 16, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-