Catalog Number

800LS-10

Brand Name

Temena

Version/Model Number

800LS-10

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)

-

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

7bba4e60-a87d-427d-872d-21ca022aaee1

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

November 28, 2017

Package DI Number

03700339701827

Quantity per Package

10

Contains DI Package

03700339711826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box