Catalog Number

SEN 2009

Brand Name

TetraSens Pediatric

Version/Model Number

SEN 2009 TetraSens Pediatric

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K220530,K220530

Product Code

KOI

Product Code Name

Stimulator, Nerve, Peripheral, Electric

Public Device Record Key

50f3b8b8-7069-4d2e-b7c9-57ef7bf0e194

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

07350012440114

Quantity per Package

15

Contains DI Package

07350012440121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box