SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle - Used to inject fluids into, or withdraw fluids - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: Used to inject fluids into, or withdraw fluids from the body. In addition, the device is d Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries.

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More Product Details

Catalog Number

-

Brand Name

SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle

Version/Model Number

140072IM

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

MEG

Product Code Name

SYRINGE, ANTISTICK

Device Record Status

Public Device Record Key

9459c183-8c4b-4642-8b3b-fa565c0124e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

20818392015724

Quantity per Package

12

Contains DI Package

10818392015727

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