Catalog Number

630938025

Brand Name

Screw Dilator

Version/Model Number

630938025

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

K990808,K990808

Product Code

GCC

Product Code Name

Dilator, Catheter

Public Device Record Key

e9f9d5e1-bab9-45a1-8f83-c7b9a8b9ef6f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

20886333004922

Quantity per Package

10

Contains DI Package

00886333004928

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box