Catalog Number

-

Brand Name

SOL-CARE Syringe with Safety Needle

Version/Model Number

32510SN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FMF

Product Code Name

Syringe, piston

Public Device Record Key

fcdfc797-7d9f-4e99-9fc3-82ac6ded5c0d

Public Version Date

April 18, 2019

Public Version Number

1

DI Record Publish Date

April 10, 2019

Package DI Number

10818392019060

Quantity per Package

50

Contains DI Package

00818392019063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box