Catalog Number

600

Brand Name

Lite Touch

Version/Model Number

600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 17, 2025

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142765,K142765,K142765,K142765

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

a2eec6ff-1bf3-48fd-9248-8f571fed45aa

Public Version Date

April 26, 2021

Public Version Number

2

DI Record Publish Date

December 17, 2020

Package DI Number

10732671106008

Quantity per Package

1

Contains DI Package

00732671006004

Package Discontinue Date

December 17, 2025

Package Status

In Commercial Distribution

Package Type

Blister Pack