Catalog Number

-

Brand Name

PROVISA

Version/Model Number

4985-162

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

Yes

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

EJB

Product Code Name

Handle, Instrument, Dental

Public Device Record Key

2d277698-79ee-4b48-8f3e-a2d896697575

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

D74449851621

Quantity per Package

1

Contains DI Package

D74449851620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box