Catalog Number

-

Brand Name

Accordion Stone Control Device; Accordion Stone Management Device

Version/Model Number

PA1305-01-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2020

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

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Public Device Record Key

e8b4eda1-fc5a-466e-ad88-8063cf0ffa03

Public Version Date

January 27, 2020

Public Version Number

5

DI Record Publish Date

June 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-