Catalog Number

-

Brand Name

Splash Medical Devices

Version/Model Number

71562

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"

Yes

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

-

Product Code

KYZ

Product Code Name

SYRINGE, IRRIGATING (NON DENTAL)

Public Device Record Key

6b9a8fbc-4d54-4c4f-959a-0f12a2e1ee98

Public Version Date

March 08, 2019

Public Version Number

1

DI Record Publish Date

February 05, 2019

Package DI Number

20809160226107

Quantity per Package

50

Contains DI Package

10809160226100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-