SOL-M™ U-100 Insulin Syringe with Fixed Needle - Intended for medical purposes for the manual - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), a Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), and for the injection of insulin into parts of the body below the surface skin.

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More Product Details

Catalog Number

-

Brand Name

SOL-M™ U-100 Insulin Syringe with Fixed Needle

Version/Model Number

110102010039

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

46bfc0d0-0b96-45af-b3c1-ab587ce9b92a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10818392015468

Quantity per Package

10

Contains DI Package

00818392015461

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