Catalog Number

-

Brand Name

Gasless Tip

Version/Model Number

601151

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)

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

4d184d08-53e3-4566-ad7f-94bdfc053e6e

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Package DI Number

10815634021003

Quantity per Package

5

Contains DI Package

00815634021006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box