Catalog Number

WA63821A

Brand Name

Olympus

Version/Model Number

WA63821A

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

-

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

K853486,K853486

Product Code

FGA

Product Code Name

Kit, Nephroscope

Public Device Record Key

7f98cc0e-10bc-4aff-88ef-47f5c2ece04a

Public Version Date

March 19, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-