Catalog Number

-

Brand Name

NA

Version/Model Number

APP-100

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

248bc8c7-4bc9-4874-9a82-f62c83c5d564

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 25, 2016

Package DI Number

10815634020358

Quantity per Package

5

Contains DI Package

00815634020351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHELF BOX