Catalog Number

682212

Brand Name

COMP TA1019M-1 DOME

Version/Model Number

682212

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

-

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Public Device Record Key

38c26277-1c8d-485c-8c33-0d0feae59f19

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

50886333622127

Quantity per Package

100

Contains DI Package

00886333622122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Bag