Catalog Number

-

Brand Name

Care Touch

Version/Model Number

LSS10

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

3199ecd1-69c1-4d1d-b02b-ab4f9f09c78a

Public Version Date

June 17, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

10370393504018

Quantity per Package

6

Contains DI Package

00370393504011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-