FO Micro Screw System FOGS-0012/1

GUDID 09353903000402

1.2 FO Guide Sleeve

FIELD ORTHOPAEDICS PTY LTD

Surgical drill guide, reusable

• Primary Device ID: 09353903000402
• NIH Device Record Key: c565825c-002c-4469-a9a6-b98f17d69175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FO Micro Screw System
• Version Model Number: FOGS-0012
• Catalog Number: FOGS-0012/1
• Company DUNS: 744008914
• Company Name: FIELD ORTHOPAEDICS PTY LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353903000402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180348

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09353903000402]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-01-21

On-Brand Devices [FO Micro Screw System]

• 09353903008484: 0.6 Single-ended Trocar K-wire 70mm 1/pkg
• 09353903001782: 0.6mm Pin Collet Insert
• 09353903002062: 1.5 FO Micro Screw 10mm (Cannulated) 1/pkg
• 09353903002055: 1.5 FO Micro Screw 9mm (Cannulated) 1/pkg
• 09353903002048: 1.5 FO Micro Screw 8mm (Cannulated) 1/pkg
• 09353903002031: 1.5 FO Micro Screw 7mm (Cannulated) 1/pkg
• 09353903002024: 1.5 FO Micro Screw 6mm (Cannulated) 1/pkg
• 09353903000426: 2.0 FO Guide Sleeve
• 09353903000419: 1.6 FO Guide Sleeve
• 09353903000402: 1.2 FO Guide Sleeve
• 09353903000396: 1.0 FO Guide Sleeve
• 09353903000389: 0.8 FO Guide Sleeve
• 09353903000372: 0.6 FO Guide Sleeve
• 09353903000303: FO Soft Tissue Protector
• 09353903001041: FO Micro Screw Kit Tray and Lid
• 09353903000457: FO Micro Screw Kit Lid
• 09353903000440: FO Micro Screw Kit Tray
• 09353903002512: FO Micro Cleaning Stylet
• 09353903000273: FO Micro Cleaning Stylet
• 09353903001072: FO Micro Screw Kit Lid
• 09353903001065: FO Micro Screw Kit Tray
• 09353903004264: 2.0 Double-ended Trocar Pin 150mm 5/pkg
• 09353903004257: 1.6 Double-ended Trocar Pin 150mm 5/pkg
• 09353903004240: 1.2 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903004233: 1.0 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903004226: 0.8 Double-ended Trocar K-wire 70mm 5/pkg
• 09353903004219: 0.6 Double-ended Trocar K-wire 70mm 5/pkg
• 09353903004202: 0.6 Single-ended Trocar K-wire 70mm 5/pkg
• 09353903001799: 0.6mm Wire Collet Insert
• 09353903000365: 2.0 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000358: 1.6 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000341: 1.2 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000334: 1.0 Double-ended Trocar K-wire 150mm 5/pkg
• 09353903000327: 0.8 Double-ended Trocar K-wire 70mm 5/pkg
• 09353903000310: 0.6 Double-ended Trocar K-wire 70mm 5/pkg
• 09353903000228: 0.6 Single-ended Trocar K-wire 70mm 5/pkg