FO Micro Screw System - FO Micro Hex Driver (Cannulated) - FIELD ORTHOPAEDICS PTY LTD

Duns Number:744008914

Device Description: FO Micro Hex Driver (Cannulated)

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More Product Details

Catalog Number

MSHX-0000/1

Brand Name

FO Micro Screw System

Version/Model Number

MSHX-0000

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

K180348

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

2004b1fc-791c-4037-a986-601e75aab5df

Public Version Date

February 21, 2019

Public Version Number

1

DI Record Publish Date

January 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIELD ORTHOPAEDICS PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 78
2 A medical device with a moderate to high risk that requires special controls. 165