Catalog Number

27448

Brand Name

Exel SecureTouch Safety Needle

Version/Model Number

27448

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)

Yes

Over the Counter (OTC)

-

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

f77aa9d1-33f9-48b9-bb73-958c8730173d

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

20020221274480

Quantity per Package

10

Contains DI Package

10020221274483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-