Catalog Number

PVT0616

Brand Name

ACCLARENT PIVOT

Version/Model Number

PVT0616

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K201115,K201115

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

24410542-e06d-44d8-98fa-98071f730da5

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Package DI Number

20705031465562

Quantity per Package

5

Contains DI Package

10705031465565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX