Exel SecureTouch Safety Needle - Safety Needle, 25G X 1 - Exel International

Duns Number:180572216

Device Description: Safety Needle, 25G X 1

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More Product Details

Catalog Number

27405

Brand Name

Exel SecureTouch Safety Needle

Version/Model Number

27405

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

6e45268e-95ba-4bef-832c-0e6ea4352506

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

20020221274053

Quantity per Package

10

Contains DI Package

10020221274056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"EXEL INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 82