Catalog Number

2213

Brand Name

LiteTouch

Version/Model Number

2213

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 12, 2026

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

K132553,K132553,K132553,K132553

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

9ac80b01-7e83-49e3-8274-127198d3469f

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

10732671122138

Quantity per Package

1

Contains DI Package

00732671022134

Package Discontinue Date

May 12, 2026

Package Status

In Commercial Distribution

Package Type

Blister Pack