Catalog Number

-

Brand Name

Procedure Products Needles

Version/Model Number

21-1835

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,K810859

Product Code

DRE

Product Code Name

Dilator, Vessel, For Percutaneous Catheterization

Public Device Record Key

d00f3c8c-d171-4d7d-b27f-a38caf702d7e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 07, 2017

Package DI Number

B1602118352

Quantity per Package

25

Contains DI Package

B1602118351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box