4.5mm x 55mm FTTCS

GUDID 00812926029184

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00812926029184
NIH Device Record Key33e86025-9e07-43e5-b498-554eb559c78b
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.5mm x 55mm FTTCS
Version Model Number200-45-255
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
GS100812926029184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926029184]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-19
Device Publish Date2019-03-11

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