Catalog Number

-

Brand Name

Comfortox

Version/Model Number

.3 CC 31 Gauge X 8 MM 100

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)

-

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

2e7b5f63-702a-479f-ae01-8cddd190235a

Public Version Date

May 14, 2018

Public Version Number

1

DI Record Publish Date

April 12, 2018

Package DI Number

10817169021947

Quantity per Package

36

Contains DI Package

00817169021940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-