Catalog Number

043000

Brand Name

Bard® SkyLite™ Tipless Nitinol Stone Basket

Version/Model Number

043000

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

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

6b5686e0-3cff-4ef4-b545-f847a1b10dd8

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

July 22, 2016

Package DI Number

10801741111508

Quantity per Package

15

Contains DI Package

00801741111501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA