Catalog Number

-

Brand Name

GNP

Version/Model Number

09583GNP

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100812,K100812,K100812

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

06403b2b-c3d9-4e3f-86c0-41365f7df70b

Public Version Date

August 31, 2022

Public Version Number

3

DI Record Publish Date

January 28, 2022

Package DI Number

00087701434303

Quantity per Package

1

Contains DI Package

00087710434349

Package Discontinue Date

August 29, 2022

Package Status

Not in Commercial Distribution

Package Type

UtiGuard