SOL-M™ Multi-Sample Needle - SOL-M™ Multi-Sample Needle 21G*1 1/2" - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: SOL-M™ Multi-Sample Needle 21G*1 1/2"

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More Product Details

Catalog Number

-

Brand Name

SOL-M™ Multi-Sample Needle

Version/Model Number

110201020005

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

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

18ac7ca5-a808-4ef3-a818-7279fef34fbf

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

July 03, 2018

Additional Identifiers

Package DI Number

20818392015410

Quantity per Package

10

Contains DI Package

10818392015413

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