Catalog Number

FG-000016

Brand Name

PolypVac®

Version/Model Number

3.3mm Microdebrider

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"

Yes

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

ERL

Product Code Name

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Public Device Record Key

e7fa8f5e-7404-4342-b90b-859ef89c98db

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 10, 2016

Package DI Number

00862519000311

Quantity per Package

4

Contains DI Package

00862519000304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box