Catalog Number

8884713100

Brand Name

Thora-Seal

Version/Model Number

8884713100

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

4878f613-a819-4d47-8a7c-5b1699ad9da4

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

00884521067298

Quantity per Package

6

Contains DI Package

00884521128319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE