Catalog Number

-

Brand Name

VisCalor Dispenser

Version/Model Number

9146

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

QGO

Product Code Name

Composite Resin Warmer

Public Device Record Key

56cf8582-885f-426b-82d7-ecb0e5cc26f8

Public Version Date

January 07, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-