BULLET Tapered Intervertebral Distractors and Drills 11-1814-2-14-2

GUDID M36411181421420

BULLET™ Tapered Intervertebral Drill Collar, 14-7mm

MEDICAL DESIGNS LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: M36411181421420
• NIH Device Record Key: c3c111d8-08a0-4bce-b128-eafba16cdeca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET Tapered Intervertebral Distractors and Drills
• Version Model Number: 11-1814-2-14-2
• Catalog Number: 11-1814-2-14-2
• 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	M36411181421420 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

Moist Heat or Steam Sterilization

[M36411181421420]

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