3.5mm x 50mm Arsenal Locking Screw

GUDID 00810028391321

TRILLIANT SURGICAL, LTD.

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 Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810028391321
NIH Device Record Key77b6bbb6-e13c-442d-9723-b6b4c0188f3c
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 50mm Arsenal Locking Screw
Version Model Number308-35-050
Company DUNS828829072
Company NameTRILLIANT SURGICAL, LTD.
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
GS100810028391321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


[00810028391321]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-09
Device Publish Date2019-10-01

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00810028391567 - Arsenal Short 5th Met Hook Plate, R2021-09-13
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00810028391581 - Arsenal U-Plate, Small, R2021-09-13

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