Catalog Number

-

Brand Name

SOL-GUARD™ TB Safety Syringe with Fixed Needle

Version/Model Number

2051516SG

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

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

bf852418-b094-4287-85bb-11c8a4bc21e2

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2017

Package DI Number

20818392016127

Quantity per Package

8

Contains DI Package

10818392016120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case