Catalog Number

SEN 2101

Brand Name

TetraGraph Pole Clamp kit

Version/Model Number

SEN 2101 Pole Clamp for TetraGraph (Optional)

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190795

Product Code

KOI

Product Code Name

Stimulator, Nerve, Peripheral, Electric

Public Device Record Key

49a5f09f-b014-435f-8641-9299e4e5f75c

Public Version Date

October 02, 2020

Public Version Number

2

DI Record Publish Date

April 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-