Tri-Staple 2.0

Basic Information

• Brand Name: Tri-Staple 2.0
• Primary DI: 10884521703766
• Version / Model: SIGCIR33MT
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-29
• Public Version: 3
• Public Version Date: 2022-05-10
• Public Version Status: Update
• Public Device Record Key: 04109245-5367-4648-a40e-17d99c6e6846

Device Description

Medium/Thick Circular Reload For use with Signia Circular Adapters

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
64256	Surgical staple loading unit, cutting	A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) and an internal cutting blade designed to be used with a surgical stapler (not included) during endoscopic or open-surgery (e.g., bowel resection to create anastomoses). The unit is designed to deploy the staples (e.g., in a straight or circular row) while the blade cuts the adjacent tissue. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521703763	GS1	PACK_OR_INNER_PACK	6	In Commercial Distribution
Primary	10884521703766	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182475	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	33	Centimeter

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 55 – 101 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 20 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity