Catalog Number

MIS-6F07

Brand Name

Introducer Kits

Version/Model Number

MIS-6F07

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

K780126,K780126,K780126

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

5a079077-4436-447e-b7fe-07ec0884d4d9

Public Version Date

March 31, 2022

Public Version Number

1

DI Record Publish Date

March 23, 2022

Package DI Number

20886333226911

Quantity per Package

50

Contains DI Package

00886333226917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box