Signia

Basic Information

• Brand Name: Signia
• Primary DI: 10884521797437
• Version / Model: SIGPHANDLE-RFB
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-17
• Public Version: 2
• Public Version Date: 2023-05-23
• Public Version Status: Update
• Public Device Record Key: 30236d09-dc5c-40e2-ab7d-a839135a4013

Device Description

Power Handle, Refurbished

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
62383	Motorized cutting stapler handpiece	A hand-held, electrically-powered proximal component of a motorized cutting stapler designed to be used during endoscopic transection and resection of tissues and the creation of anastomoses, and/or during open surgery. It is typically a pistol-like device with battery pack, motor, and controls, and is intended to accept a separate connector endpiece/loading unit (neither are included) to cut the tissue and simultaneously apply surgical staples along the cut line. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521797437	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201672	000

Storage Conditions

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