4.0mm x 12mm Tiger Cannulated Screw

GUDID 00812926021096

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00812926021096
NIH Device Record Keyba68ace6-00bc-4432-9d7d-58e30ea89bdc
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.0mm x 12mm Tiger Cannulated Screw
Version Model Number200-40-012
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

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter
Length12 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100812926021096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


[00812926021096]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-25

Devices Manufactured by TRILLIANT SURGICAL, LTD.

00810028391512 - Arsenal Petite MPJ Plate, L, 0°2021-09-13
00810028391529 - Arsenal Petite MPJ Plate, R, 0°2021-09-13
00810028391536 - Arsenal Petite MPJ Plate, L, 5°2021-09-13
00810028391543 - Arsenal Petite MPJ Plate, R, 5°2021-09-13
00810028391550 - Arsenal Short 5th Met Hook Plate, L2021-09-13
00810028391567 - Arsenal Short 5th Met Hook Plate, R2021-09-13
00810028391574 - Arsenal U-Plate, Small, L2021-09-13
00810028391581 - Arsenal U-Plate, Small, R2021-09-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.