FIREFLY®

GUDID 00851662007186

Patient-Specific Bone Model

MIGHTY OAK MEDICAL, INC.

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00851662007186
• NIH Device Record Key: 52d4ca3e-3d9d-4314-b896-49ca4b0e3bed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIREFLY®
• Version Model Number: FF-202-XX
• Company DUNS: 024112263
• Company Name: MIGHTY OAK MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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

Customer Support Contacts

• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com
• Phone: (720)398-9703
• Email: mwylie@mightyoakmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851662007186 [Primary]

FDA Product Code

• PQC: Pedicle Screw Placement Guide

Sterilization

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

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

[00851662007186]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-10-18

On-Brand Devices [FIREFLY®]

• 00851662007209: PATIENT-SPECIFIC MIDLINE GUIDE
• 00851662007193: Patient-Specific Midline Guide
• 00851662007186: Patient-Specific Bone Model
• 00851662007179: Drill Bit
• 00851662007162: Drill Bit
• 00851662007155: Instrument Sleeve
• 00851662007148: Instrument Sleeve
• 00851662007131: Reamer
• 00851662007124: FIREFLY® Pedicle Marker
• 00851662007117: Pedicle Marker
• 00851662007100: Handle
• 00851662007094: Drill Bit
• 00851662007087: Drill Bit
• 00851662007070: Screw Holding Sleeve
• 00851662007063: Screwdriver Bit
• 00851662007056: Fixation Screw
• 00851662007049: Fixation Screw
• 00851662007032: Instrument Sleeve
• 00851662007025: Patient-Specific Bone Model
• 00851662007018: Patient-Specific Pedicle Screw Guide
• 00851662007001: Patient-Specific Pedicle Screw Guide