Catalog Number

330-10005

Brand Name

Health-Tec Endo Refrigerant Spray

Version/Model Number

330-10005

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

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

f0d3af78-b9e2-4488-87d9-0b8d4f3259cb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 17, 2017

Package DI Number

D773330100052

Quantity per Package

12

Contains DI Package

D773330100051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-