Catalog Number

-

Brand Name

Bioseal

Version/Model Number

17321/20

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

0143a8d9-15fe-43b5-8c24-679196529c74

Public Version Date

January 29, 2020

Public Version Number

1

DI Record Publish Date

January 21, 2020

Package DI Number

10630094173211

Quantity per Package

20

Contains DI Package

00630094173214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case