ACCLARENT PIVOT - ACCLARENT PIVOT Navigation Balloon Dilation - ACCLARENT, INC.

Duns Number:361092450

Device Description: ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK

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More Product Details

Catalog Number

PVT0616NZ

Brand Name

ACCLARENT PIVOT

Version/Model Number

PVT0616NZ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Product Code Details

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Device Record Status

Public Device Record Key

eb04089f-83b1-4194-a46c-21692f4e5fb9

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCLARENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 83
2 A medical device with a moderate to high risk that requires special controls. 43