Catalog Number

LSS-100

Brand Name

Locking Syringe

Version/Model Number

LSS-100

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

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

K943651,K943651,K943651

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

5639ad4f-7b40-4828-ac8e-ed17cdc75719

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10813079020018

Quantity per Package

25

Contains DI Package

00813079020011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton