BULLET Tapered Intervertebral Distractors and Drills 11-1814-FD1-08

GUDID M364111814FD1080

BULLET™ Tapered Intervertebral Distractor, 8-12mm

MEDICAL DESIGNS LLC

General internal orthopaedic fixation system implantation kit
Primary Device IDM364111814FD1080
NIH Device Record Keyceeaeb1b-d6ad-4cf5-9a5c-d68e6302803a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBULLET Tapered Intervertebral Distractors and Drills
Version Model Number11-1814-FD1-08
Catalog Number11-1814-FD1-08
Company DUNS003815548
Company NameMEDICAL DESIGNS LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com
Phone605-275-1032
Emailkspielman@medicaldesignsllc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM364111814FD1080 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

[M364111814FD1080]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-15
Device Publish Date2021-02-05

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

M364111814FD21610BULLET™ Tapered Intervertebral Drill, 16-8mm
M364111814FD21410BULLET™ Tapered Intervertebral Drill, 14-7mm
M364111814FD21210BULLET™ Tapered Intervertebral Drill, 12-6mm
M364111814FD21010BULLET™ Tapered Intervertebral Drill, 10-5mm
M364111814FD20810BULLET™ Tapered Intervertebral Drill, 8-4mm
M364111814FD1120BULLET™ Tapered Intervertebral Distractor, 12-16mm
M364111814FD1100BULLET™ Tapered Intervertebral Distractor, 10-14mm
M364111814FD1080BULLET™ Tapered Intervertebral Distractor, 8-12mm
M364111814FD1060BULLET™ Tapered Intervertebral Distractor, 6-10mm
M36411181421620BULLET™ Tapered Intervertebral Drill Collar, 16-8mm
M36411181421420BULLET™ Tapered Intervertebral Drill Collar, 14-7mm
M36411181421220BULLET™ Tapered Intervertebral Drill Collar, 12-6mm
M36411181421020BULLET™ Tapered Intervertebral Drill Collar, 10-5mm
M36411181420820BULLET™ Tapered Intervertebral Drill Collar, 8-4mm
M36411181420620BULLET™ Tapered Intervertebral Drill Collar, 6-3mm
M364111814205BULLET™ Tapered Intervertebral Drill Collar Allen Wrench
M364111814204BULLET™ Tapered Intervertebral Drill Collar Set Screw
M361111814FD20610BULLET™ Tapered Intervertebral Drill, 6-3mm
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