Catalog Number

65220733

Brand Name

Provil Novo

Version/Model Number

65220733

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

K973694,K973694

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

bf93e871-48b1-465b-994f-709d22387199

Public Version Date

August 16, 2018

Public Version Number

1

DI Record Publish Date

July 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-