Catalog Number

286202102

Brand Name

SENTIO

Version/Model Number

286202102

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

K173526,K173526

Product Code

ETN

Product Code Name

STIMULATOR, NERVE

Public Device Record Key

ec82a7f2-0285-4b18-afe6-7f7f29b837af

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-