NA - Calibrated Passing Pin Drill Tip 2.4mm X 38.1cm, - DEPUY MITEK, LLC

Duns Number:190572854

Device Description: Calibrated Passing Pin Drill Tip 2.4mm X 38.1cm, 20-80mm (Plus or Minus 5 Percent)

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More Product Details

Catalog Number

254729

Brand Name

NA

Version/Model Number

254729

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

FZX

Product Code Name

Guide, surgical, instrument

Device Record Status

Public Device Record Key

36c32645-438c-42ec-aa1b-345e2a87d62c

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY MITEK, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 560
2 A medical device with a moderate to high risk that requires special controls. 479