4.5mm x 3.0mm x 10mm Two-Step Hammer Toe Implant

GUDID 00812926022086

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00812926022086
NIH Device Record Keyc95d962e-e8cc-494a-8a60-02f6966888e6
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.5mm x 3.0mm x 10mm Two-Step Hammer Toe Implant
Version Model Number204-30-110
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100812926022086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


[00812926022086]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-13

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