KMEDIC - DRILL BIT JACOBS CHUCK 3.5 MILLIMETER , 180/70 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: DRILL BIT JACOBS CHUCK 3.5 MILLIMETER , 180/70 MILLIMETER , LONG

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More Product Details

Catalog Number

KM48082

Brand Name

KMEDIC

Version/Model Number

IPN014455

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

ad16fb04-c02d-4b49-b0f7-9f118222b7a8

Public Version Date

December 16, 2019

Public Version Number

3

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26