Catalog Number

-

Brand Name

MIP Minimal Invasive PCNL

Version/Model Number

27840CFS

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

K940594

Product Code

FGA

Product Code Name

Kit, nephroscope

Public Device Record Key

c72022a7-1300-4335-aff0-7eaea102e3a5

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

August 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-