I.CO.S® - The long cannulated drill, with a three lip tip - NEWDEAL

Duns Number:536935331

Device Description: The long cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, The long cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is used to drill the bone for the insertion of the 4.0mm.

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More Product Details

Catalog Number

-

Brand Name

I.CO.S®

Version/Model Number

119516ND

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"

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 Details

Product Code

HTW

Product Code Name

BIT, DRILL

Device Record Status

Public Device Record Key

28de04f1-d26c-4c46-8413-4f43ed0ab1aa

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

May 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEWDEAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388
2 A medical device with a moderate to high risk that requires special controls. 235