Catalog Number

-

Brand Name

Tenex Health TX®

Version/Model Number

554-1001-001

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"

Yes

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

K123640,K153299,K181367

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

f6ac5564-7a9c-4536-8611-281df07b5732

Public Version Date

July 23, 2020

Public Version Number

1

DI Record Publish Date

July 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-