Catalog Number

290-HT9003

Brand Name

Health-Tec VPS Impression Material

Version/Model Number

290-HT9003

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K801380,K801380,K801380

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

5e6c4148-f4cf-45c6-abbb-ff20a43f2a74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D773290HT90033

Quantity per Package

10

Contains DI Package

D773290HT90031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-