Catalog Number

HTC-0000

Brand Name

Inion Cautery

Version/Model Number

1

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

-

Product Code

HQP

Product Code Name

Unit, cautery, thermal, battery-powered

Public Device Record Key

fa2b3cff-8a87-48a6-94fb-b4f13bdfcc2a

Public Version Date

August 12, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

06438408000010

Quantity per Package

10

Contains DI Package

06438408000003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX