Catalog Number

-

Brand Name

Surgical handpiece 1:1

Version/Model Number

1951nou

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

K042434

Product Code

ERL

Product Code Name

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

Public Device Record Key

6dde0942-b33e-4d8c-81d3-7b95a6d27bd8

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

April 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-