BULLET Tapered Intervertebral Distractor and Drills

GUDID M364111814FD1040

BULLET Tapered Intervertebral Distractor, 4-8mm

MEDICAL DESIGNS LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: M364111814FD1040
• NIH Device Record Key: 7abef74b-817b-4879-8862-09d9b440a480
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET Tapered Intervertebral Distractor and Drills
• Version Model Number: 11-1814-FD1-04
• 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	M364111814FD1040 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

Moist Heat or Steam Sterilization

[M364111814FD1040]

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

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