INSTRUMENT - DRILL WITHOUT STOP (2 PER PKG) - Howmedica Osteonics Corp.

Duns Number:058311945

Device Description: DRILL WITHOUT STOP (2 PER PKG)

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More Product Details

Catalog Number

3170-0000

Brand Name

INSTRUMENT

Version/Model Number

3170-0000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HTW

Product Code Name

BIT, DRILL

Device Record Status

Public Device Record Key

aec86e89-090a-486a-8021-abbd4a6b938e

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

November 13, 2017

Additional Identifiers

Package DI Number

37613327215602

Quantity per Package

2

Contains DI Package

07613327215601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"HOWMEDICA OSTEONICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5091
2 A medical device with a moderate to high risk that requires special controls. 10216
3 A medical device with high risk that requires premarket approval 32