Catalog Number

1504272

Brand Name

Tisseel/Artiss Spray Set

Version/Model Number

1504272

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

FMF

Product Code Name

Syringe, piston

Public Device Record Key

233e8f5d-be35-4c27-93f4-125eac616635

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

55413760476211

Quantity per Package

10

Contains DI Package

05413760476216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE