GEO Bone Screw System - Drill Bit 5.0mmx230mm ZH Cannulated - GRAMERCY EXTREMITY ORTHOPEDICS LLC

Duns Number:080068420

Device Description: Drill Bit 5.0mmx230mm ZH Cannulated

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More Product Details

Catalog Number

-

Brand Name

GEO Bone Screw System

Version/Model Number

21250230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K161904

Product Code Details

Product Code

HTW

Product Code Name

BIT, DRILL

Device Record Status

Public Device Record Key

8a662a91-adf2-42d2-8683-4d296a387a68

Public Version Date

November 22, 2018

Public Version Number

2

DI Record Publish Date

October 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAMERCY EXTREMITY ORTHOPEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 65
2 A medical device with a moderate to high risk that requires special controls. 626