Catalog Number

L-31010K

Brand Name

REVEAL Clear Matrix VPS

Version/Model Number

L-31010K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 2019

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

K962680

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

b2ca49c1-02c9-4b78-93ca-28e9dc289ea7

Public Version Date

April 22, 2019

Public Version Number

2

DI Record Publish Date

November 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-