Arsenal U-Plate, Small, R

GUDID 00810028391581

TRILLIANT SURGICAL, LTD.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00810028391581
NIH Device Record Key864fcd75-62bb-4a29-a80a-0f2ce3359648
Commercial Distribution StatusIn Commercial Distribution
Brand NameArsenal U-Plate, Small, R
Version Model Number300-85-006
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
GS100810028391581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


[00810028391581]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-13
Device Publish Date2021-09-03

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
00810028391581 - Arsenal U-Plate, Small, R2021-09-13

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