Catalog Number

601

Brand Name

Igloo® Wound Irrigation OTC

Version/Model Number

601

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)

-

Over the Counter (OTC)

Yes

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

ffa3a353-08fd-4474-9fb6-7bc03365a0da

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

20859911004027

Quantity per Package

12

Contains DI Package

00859911004023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-