3.5mm x 55mm Arsenal Screw

GUDID 00810028391970

Trilliant Surgical, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810028391970
NIH Device Record Keyf1644487-ff0a-49ba-9b1a-ffe04321c98a
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 55mm Arsenal Screw
Version Model Number307-35-055
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
GS100810028391970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

Moist Heat or Steam Sterilization


[00810028391970]

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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00810028393530 - 12mm STAR E+ Sliding Core STAR Total Ankle2024-08-14
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