Catalog Number

-

Brand Name

Thopaz Sealing Cap

Version/Model Number

079.0039

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130210,K130210

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

b97840e0-e321-4fb4-b3f5-041354163404

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

June 07, 2017

Package DI Number

07612367038560

Quantity per Package

20

Contains DI Package

07612367020534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-