10mm x 10mm Staple System

GUDID 00812926027517

10mm Sniper Sterile Staple Kit

TRILLIANT SURGICAL, LTD.

Surgical staple loading unit, non-cutting

• Primary Device ID: 00812926027517
• NIH Device Record Key: bd4b0066-a6ee-469b-b7f7-5c7933b8f2c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10mm x 10mm Staple System
• Version Model Number: 500-10-001
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter
• Width: 10 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926027517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162354

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-07-05

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, 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