4.0mm x 54mm Gridlock Ankle Syndesmotic Screw LP

GUDID 00812926027302

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00812926027302
NIH Device Record Keyf10f6060-b30d-4e48-a94a-9a92ec9cd4ba
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0mm x 54mm Gridlock Ankle Syndesmotic Screw LP
Version Model Number306-41-054
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

Length54 Millimeter
Length54 Millimeter
Length54 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter
Outer Diameter4 Millimeter
Length54 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812926027302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

Moist Heat or Steam Sterilization


[00812926027302]

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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