SOL-M™ Hypodermic Needle - Sterile hypodermic needles intended to inject - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin.

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More Product Details

Catalog Number

-

Brand Name

SOL-M™ Hypodermic Needle

Version/Model Number

112115

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

c465a4ec-ea46-4233-8554-75e8e19a82fc

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10818392015116

Quantity per Package

100

Contains DI Package

00818392015119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SOL-MILLENNIUM MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 161