Catalog Number

292143

Brand Name

Septaline

Version/Model Number

292143

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXR

Product Code Name

APPLICATOR, RESIN

Public Device Record Key

9fbf00fa-57f6-415d-ab1e-5d9b1caa9f04

Public Version Date

October 05, 2022

Public Version Number

3

DI Record Publish Date

August 13, 2022

Package DI Number

10789594000005

Quantity per Package

400

Contains DI Package

20789594000002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON