Catalog Number

-

Brand Name

Procedure Products Needle

Version/Model Number

20-1827

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

K810859

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

0c3bbb1a-7c29-444d-9554-fa4460cd1f5d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-