Catalog Number

SY3WN

Brand Name

Rospital Productos Medicos

Version/Model Number

SY3WN

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

2241d0a5-3dd1-4666-b375-8a5109b23171

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Package DI Number

10812460026929

Quantity per Package

100

Contains DI Package

00812460026922

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER