8mm x 8mm Staple System

GUDID 00812926027500

8mm Sniper Sterile Staple Kit

TRILLIANT SURGICAL, LTD.

Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting

• Primary Device ID: 00812926027500
• NIH Device Record Key: bd0c381a-af98-43cd-83f4-aaf989329279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8mm x 8mm Staple System
• Version Model Number: 500-08-001
• 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: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter
• Width: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926027500 [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

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