Catalog Number

2102000100

Brand Name

HSW LIGMAJECT® II

Version/Model Number

2102000100

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"

-

For Single-Use

-

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

EJI

Product Code Name

Syringe, Cartridge

Public Device Record Key

4dbc23c7-ac49-436b-8ee0-c788552abc97

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

November 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-