MICROPOWER - Micropower High Speed Drill, Permanent Lever - Conmed Corporation

Duns Number:071595540

Device Description: Micropower High Speed Drill, Permanent Lever

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More Product Details

Catalog Number

00602102600

Brand Name

MICROPOWER

Version/Model Number

6021-026

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

K072706,K072706,K072706

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

84367843-5ced-4f80-bcb3-7f5e65066e55

Public Version Date

July 13, 2022

Public Version Number

2

DI Record Publish Date

September 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95