Catalog Number

RFPERKX

Brand Name

OlyPercX PCNL Basket

Version/Model Number

ROKP1001ST245

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"

Yes

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

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Public Device Record Key

47867af5-6767-4924-8c46-0b1733094b9a

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2020

Package DI Number

03700512978190

Quantity per Package

1

Contains DI Package

03700512968191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 1