BULLET Tapered Intervertebral Distractors and Drills 11-1814-FD1-12

GUDID M364111814FD1120

BULLET™ Tapered Intervertebral Distractor, 12-16mm

MEDICAL DESIGNS LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: M364111814FD1120
• NIH Device Record Key: 2f29c9a5-4804-4838-b70a-c3427b021f2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET Tapered Intervertebral Distractors and Drills
• Version Model Number: 11-1814-FD1-12
• Catalog Number: 11-1814-FD1-12
• Company DUNS: 003815548
• Company Name: MEDICAL DESIGNS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com
• Phone: 605-275-1032
• Email: kspielman@medicaldesignsllc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M364111814FD1120 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

[M364111814FD1120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-15
• Device Publish Date: 2021-02-05

On-Brand Devices [BULLET Tapered Intervertebral Distractors and Drills ]

• M364111814FD21610: BULLET™ Tapered Intervertebral Drill, 16-8mm
• M364111814FD21410: BULLET™ Tapered Intervertebral Drill, 14-7mm
• M364111814FD21210: BULLET™ Tapered Intervertebral Drill, 12-6mm
• M364111814FD21010: BULLET™ Tapered Intervertebral Drill, 10-5mm
• M364111814FD20810: BULLET™ Tapered Intervertebral Drill, 8-4mm
• M364111814FD1120: BULLET™ Tapered Intervertebral Distractor, 12-16mm
• M364111814FD1100: BULLET™ Tapered Intervertebral Distractor, 10-14mm
• M364111814FD1080: BULLET™ Tapered Intervertebral Distractor, 8-12mm
• M364111814FD1060: BULLET™ Tapered Intervertebral Distractor, 6-10mm
• M36411181421620: BULLET™ Tapered Intervertebral Drill Collar, 16-8mm
• M36411181421420: BULLET™ Tapered Intervertebral Drill Collar, 14-7mm
• M36411181421220: BULLET™ Tapered Intervertebral Drill Collar, 12-6mm
• M36411181421020: BULLET™ Tapered Intervertebral Drill Collar, 10-5mm
• M36411181420820: BULLET™ Tapered Intervertebral Drill Collar, 8-4mm
• M36411181420620: BULLET™ Tapered Intervertebral Drill Collar, 6-3mm
• M364111814205: BULLET™ Tapered Intervertebral Drill Collar Allen Wrench
• M364111814204: BULLET™ Tapered Intervertebral Drill Collar Set Screw
• M361111814FD20610: BULLET™ Tapered Intervertebral Drill, 6-3mm