Care Touch - Care Touch 3ml Luer Lock Syringe with Needle, 25g - FUTURE DIAGNOSTICS LLC

Duns Number:080113296

Device Description: Care Touch 3ml Luer Lock Syringe with Needle, 25g x 5/8"

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More Product Details

Catalog Number

-

Brand Name

Care Touch

Version/Model Number

SLN2558

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K130230,K130230,K130230

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

0f30b4a1-412f-4dee-8de7-78a4f8f0a2dd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 30, 2016

Additional Identifiers

Package DI Number

10370393560014

Quantity per Package

12

Contains DI Package

00370393560017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FUTURE DIAGNOSTICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5