SOL-M™ Luer Lock Syringe with Exchangeable Needle - Used to inject medicines and vaccines into, or - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: Used to inject medicines and vaccines into, or withdraw fluids from the body.

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More Product Details

Catalog Number

-

Brand Name

SOL-M™ Luer Lock Syringe with Exchangeable Needle

Version/Model Number

1832510

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

8c949bc5-ac96-4e76-b940-7353f91515a1

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

20818392010033

Quantity per Package

8

Contains DI Package

10818392010036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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