SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder - SOL-CARE Safety Multi-Sample Needle with - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 21G*1 1/4

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More Product Details

Catalog Number

-

Brand Name

SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder

Version/Model Number

SMSNH21125

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

5477a47f-ec99-4dba-92ee-a966cd15cc96

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 16, 2019

Additional Identifiers

Package DI Number

20818392014956

Quantity per Package

8

Contains DI Package

10818392014959

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