Catalog Number

32-1328

Brand Name

DeRoyal

Version/Model Number

32-1328

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

83be3433-d0bc-4343-a056-fed222320980

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

50749756113828

Quantity per Package

24

Contains DI Package

00749756113823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case