4.0mm x 44mm Arsenal Screw

GUDID 00810028392304

Trilliant Surgical, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810028392304
NIH Device Record Key2067d9c3-f323-4323-9721-487b4feed5d1
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0mm x 44mm Arsenal Screw
Version Model Number307-40-044
Company DUNS828829072
Company NameTrilliant Surgical, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028392304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


[00810028392304]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-10
Device Publish Date2022-05-02

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00810028395015 - 3.0/4.0 Pilot Drill2024-06-17
00810028395077 - 2.0/2.4 Countersink2024-06-17
00810028395084 - 3.0/4.0 Countersink2024-06-17
00810028395091 - 2.0 Proximal Drill2024-06-17
00810028395107 - 2.4 Proximal Drill2024-06-17
00810028395114 - 3.0 Proximal Drill2024-06-17
00810028395121 - 4.0 Proximal Drill2024-06-17

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