Catalog Number

06400

Brand Name

Tecnimed - Hammacher

Version/Model Number

VisioFocus

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122412,K122412

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

3d427329-64f0-4b64-bdae-3da0a446a8b4

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Package DI Number

00182097000696

Quantity per Package

90

Contains DI Package

00182097000689

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box