Catalog Number

-

Brand Name

Sense Medical

Version/Model Number

10700

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

K895337,K895337,K895337

Product Code

HAM

Product Code Name

Apparatus, Electrosurgical

Public Device Record Key

57e457cd-4363-4984-a2f6-d936dd103e0c

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

July 16, 2016

Package DI Number

20841019110076

Quantity per Package

50

Contains DI Package

00841019110072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-