Catalog Number

601

Brand Name

LiteTouch

Version/Model Number

601

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

aeb373e9-17fe-4ad6-ad26-4de8a6fd1d56

Public Version Date

April 26, 2021

Public Version Number

2

DI Record Publish Date

December 17, 2020

Package DI Number

10732671106015

Quantity per Package

1

Contains DI Package

00732671006011

Package Discontinue Date

December 17, 2025

Package Status

In Commercial Distribution

Package Type

Blister Pack