Tri-Staple 2.0

Basic Information

• Brand Name: Tri-Staple 2.0
• Primary DI: 10884521703711
• Version / Model: SIGCIRIC
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-29
• Public Version: 3
• Public Version Date: 2022-10-17
• Public Version Status: Update
• Public Device Record Key: 0feadac4-6997-46de-8903-b6db0ca102d0
• Distribution End Date: 2022-10-12

Device Description

Irrigation Channel; For use with Circular Reloads

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDW	Staple, implantable	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64257	Surgical instrument irrigation channel	A length of invasive flexible or semi-flexible tube designed to be attached to a surgical instrument (e.g., surgical stapler) to direct irrigation fluids to the surgical site; it may in addition be intended to allow for introduction of air to facilitate procedures such as staple line leak testing, however it is not intended for medical gas insufflation or suction. It is intended to be used in combination with devices that do not have an integrated irrigation channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521703718	GS1	PACK_OR_INNER_PACK	6	Not in Commercial Distribution	2022-10-12
Primary	10884521703711	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182475	000