Catalog Number

1902-000-010

Brand Name

Hydrate

Version/Model Number

HYDRATE, INT, NOR,S,HY 195-014

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

b85ca0d6-7959-4eda-99a3-69677c700e5b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 05, 2017

Package DI Number

10816349011464

Quantity per Package

5

Contains DI Package

00816349011467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton