Catalog Number

-

Brand Name

MicroTaper™ Safety Introducer Set

Version/Model Number

SA-04-G060

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

K151076,K151076

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

146548e7-82b2-4c80-8b29-86095d655f3a

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

20860327000220

Quantity per Package

10

Contains DI Package

10860327000223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-