StealthFix Intraosseous Fixation System

GUDID 00810082898545

StealthFix Non-sterile Instrument Case

Medartis Inc.

Device sterilization/disinfection container, reusable
Primary Device ID00810082898545
NIH Device Record Keye9a7faa3-9977-4775-a86b-dafeb9420c9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealthFix Intraosseous Fixation System
Version Model NumberSF8011
Company DUNS192756786
Company NameMedartis Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810082898545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


[00810082898545]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

On-Brand Devices [StealthFix Intraosseous Fixation System]

00810082898644StealthFix STD Implant Tamp
00810082898637StealthFix Small Implant Tamp
00810082898620StealthFix STD 20 Guide LowPro
00810082898613StealthFix STD 15 Drill Saw Guide LowPro
00810082898606StealthFix Small Drill Saw Guide LowPro
00810082898590StealthFix Non-sterile 150mm K-wire Cage
00810082898583StealthFix Non-sterile 100mm K-wire Cage
00810082898576StealthFix Non-sterile Implant Caddy Lid
00810082898569StealthFix Non-sterile Implant Caddy
00810082898552StealthFix Non-sterile Instrument Lid
00810082898545StealthFix Non-sterile Instrument Case
00810082898163StealthFix Fully Threaded Headless Screw Size 26
00810082898156StealthFix Fully Threaded Headless Screw Size 24
00810082898149StealthFix Fully Threaded Headless Screw Size 22
00810082898132StealthFix Fully Threaded Headless Screw Size 20
00810082898125StealthFix Fully Threaded Headless Screw Size 18
00810082898118StealthFix Fully Threaded Headless Screw Size 16
00810082898101StealthFix Fully Threaded Headed Screw Size 38
00810082898095StealthFix Fully Threaded Headed Screw Size 36
00810082898088StealthFix Fully Threaded Headed Screw Size 34
00810082898071StealthFix Fully Threaded Headed Screw Size 32
00810082898064StealthFix Fully Threaded Headed Screw Size 30
00810082898057StealthFix Fully Threaded Headed Screw Size 28
00810082898040StealthFix Fully Threaded Headed Screw Size 26
00810082898033StealthFix Fully Threaded Headed Screw Size 24
00810082898026StealthFix Fully Threaded Headed Screw Size 22
00810082898019StealthFix Fully Threaded Headed Screw Size 20
00810082898002StealthFix Fully Threaded Headed Screw Size 18
00810082894523StealthFix Fully Threaded Headed Screw Size 16
00810082894295StealthFix Fully Threaded Headless Screw Size 38
00810082894288StealthFix Fully Threaded Headless Screw Size 36
00810082894271StealthFix Fully Threaded Headless Screw Size 34
00810082894264StealthFix Fully Threaded Headless Screw Size 32
00810082894257StealthFix Fully Threaded Headless Screw Size 30
00810082894240StealthFix Fully Threaded Headless Screw Size 28

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