Catalog Number

0035830

Brand Name

Ear and Ulcer Syringe

Version/Model Number

0035830

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

a10eb6f0-857b-4536-a5d0-923ab05e9c73

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

10801741049283

Quantity per Package

50

Contains DI Package

00801741049286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA