FO Micro Screw System BTSC00001

GUDID 09353903002024

1.5 FO Micro Screw 6mm (Cannulated) 1/pkg

FIELD ORTHOPAEDICS PTY LTD

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID09353903002024
NIH Device Record Key170ed1d3-a07e-4f65-aa01-3b2c0b7e85ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameFO Micro Screw System
Version Model NumberCPN000001
Catalog NumberBTSC00001
Company DUNS744008914
Company NameFIELD ORTHOPAEDICS PTY LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109353903002024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09353903002024]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-31
Device Publish Date2020-03-23

On-Brand Devices [FO Micro Screw System]

093539030084840.6 Single-ended Trocar K-wire 70mm 1/pkg
093539030017820.6mm Pin Collet Insert
093539030020621.5 FO Micro Screw 10mm (Cannulated) 1/pkg
093539030020551.5 FO Micro Screw 9mm (Cannulated) 1/pkg
093539030020481.5 FO Micro Screw 8mm (Cannulated) 1/pkg
093539030020311.5 FO Micro Screw 7mm (Cannulated) 1/pkg
093539030020241.5 FO Micro Screw 6mm (Cannulated) 1/pkg
093539030004262.0 FO Guide Sleeve
093539030004191.6 FO Guide Sleeve
093539030004021.2 FO Guide Sleeve
093539030003961.0 FO Guide Sleeve
093539030003890.8 FO Guide Sleeve
093539030003720.6 FO Guide Sleeve
09353903000303FO Soft Tissue Protector
09353903001041FO Micro Screw Kit Tray and Lid
09353903000457FO Micro Screw Kit Lid
09353903000440FO Micro Screw Kit Tray
09353903002512FO Micro Cleaning Stylet
09353903000273FO Micro Cleaning Stylet
09353903001072FO Micro Screw Kit Lid
09353903001065FO Micro Screw Kit Tray
093539030042642.0 Double-ended Trocar Pin 150mm 5/pkg
093539030042571.6 Double-ended Trocar Pin 150mm 5/pkg
093539030042401.2 Double-ended Trocar K-wire 150mm 5/pkg
093539030042331.0 Double-ended Trocar K-wire 150mm 5/pkg
093539030042260.8 Double-ended Trocar K-wire 70mm 5/pkg
093539030042190.6 Double-ended Trocar K-wire 70mm 5/pkg
093539030042020.6 Single-ended Trocar K-wire 70mm 5/pkg
093539030017990.6mm Wire Collet Insert
093539030003652.0 Double-ended Trocar K-wire 150mm 5/pkg
093539030003581.6 Double-ended Trocar K-wire 150mm 5/pkg
093539030003411.2 Double-ended Trocar K-wire 150mm 5/pkg
093539030003341.0 Double-ended Trocar K-wire 150mm 5/pkg
093539030003270.8 Double-ended Trocar K-wire 70mm 5/pkg
093539030003100.6 Double-ended Trocar K-wire 70mm 5/pkg
093539030002280.6 Single-ended Trocar K-wire 70mm 5/pkg

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