Tri-Staple 2.0

Basic Information

• Brand Name: Tri-Staple 2.0
• Primary DI: 10884521717602
• Version / Model: SIGTRSB45AMT
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-30
• Public Version: 4
• Public Version Date: 2021-12-07
• Public Version Status: Update
• Public Device Record Key: bf71a7c2-ae71-464c-ae0c-13bc2cd4a01f

Device Description

Reinforced Intelligent Reload, For use with Signia stapling system

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: MR Conditional
• 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
35615	Surgical staple loading unit, non-cutting	A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521717609	GS1	PACK_OR_INNER_PACK	6	In Commercial Distribution
Primary	10884521717602	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173270	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Medium/Thick;
Length	45	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -29 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 55 – 101 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 63 – 94 Degrees Fahrenheit