Catalog Number

KIT-099-17

Brand Name

Elite Transitionless Micro-Introducer Kit

Version/Model Number

KIT-099-17

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"

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

OFL

Product Code Name

Percutaneous Sheath Introducer Kit

Public Device Record Key

e0a0154d-1e97-44c4-abea-10b19aeb881e

Public Version Date

August 23, 2022

Public Version Number

1

DI Record Publish Date

August 15, 2022

Package DI Number

10841268110011

Quantity per Package

10

Contains DI Package

00841268110014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box