Catalog Number

IG1000

Brand Name

Centurion

Version/Model Number

IG1000

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

6d66972c-8c44-45a3-8d27-ae2458b61ede

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 01, 2022

Package DI Number

10653160186434

Quantity per Package

12

Contains DI Package

00653160186437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE