Arsenal Large Lapidus Plate, R

GUDID 00810028390195

TRILLIANT SURGICAL, LTD.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Primary Device ID	00810028390195
NIH Device Record Key	56130415-4339-4f50-8e08-5e8ffdbcb0a8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Arsenal Large Lapidus Plate, R
Version Model Number	300-83-006
Company DUNS	828829072
Company Name	TRILLIANT SURGICAL, LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810028390195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191009

FDA Product Code

HRS	Plate, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

[00810028390195]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-10-09
Device Publish Date	2019-10-01

Devices Manufactured by TRILLIANT SURGICAL, LTD.

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

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