Catalog Number

-

Brand Name

Care Touch

Version/Model Number

CTS6050

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

b8100c54-7004-486f-839e-666ec36a8cdc

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

August 31, 2016

Package DI Number

10370393540504

Quantity per Package

8

Contains DI Package

00370393540507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-