RapidCross™ - PTA A14BX040210170 RAPIDCROSS V03 - Covidien LP

Duns Number:968903703

Device Description: PTA A14BX040210170 RAPIDCROSS V03

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More Product Details

Catalog Number

-

Brand Name

RapidCross™

Version/Model Number

A14BX040210170

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"

-

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

K130911

Product Code Details

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Device Record Status

Public Device Record Key

4a37cf4b-621d-46d4-9f7c-b278edfc40a1

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

April 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40