ROCASTONE Extractor - 1.9Fr - Tipless Basket: 16mm - Promepla

Duns Number:401020409

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ROSZ1900ST

Brand Name

ROCASTONE Extractor - 1.9Fr - Tipless Basket: 16mm

Version/Model Number

ROSZ1900ST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Device Record Status

Public Device Record Key

abc93abb-bd59-4a76-94c2-7c7db18efd75

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

03700512982760

Quantity per Package

4

Contains DI Package

03700512972761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2

"PROMEPLA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 152