Catalog Number

-

Brand Name

GrebSet® micro-introducer kit

Version/Model Number

7941

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

ada7bb33-7b06-45f5-a1a6-8b5e7a085328

Public Version Date

November 11, 2019

Public Version Number

5

DI Record Publish Date

September 05, 2016

Package DI Number

M20679411

Quantity per Package

10

Contains DI Package

M20679410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box