Catalog Number

682084

Brand Name

TA1010ND

Version/Model Number

682084

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

5af3495e-52ea-4ecc-8742-e27aa87d7d27

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

50886333620840

Quantity per Package

120

Contains DI Package

00886333620845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Pouch