Signia

Basic Information

• Brand Name: Signia
• Primary DI: 10884521845497
• Version / Model: SIGCIRXL
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-29
• Public Version: 4
• Public Version Date: 2025-06-24
• Public Version Status: Update
• Public Device Record Key: 38367a4e-ebd7-4054-8e74-004e86ab8106

Device Description

SIGNIA CIRCULAR ADAPTER XL LENGTH FT

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAG	Stapler, surgical	General Hospital	878.4740	2
GDW	Staple, implantable	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62384	Endoscopic cutting stapler connector, electronic-sensing	A rod-like component of an endoscopic cutting stapler with electronic sensors intended to enable connection between the stapler handpiece and the endpiece/loading unit with dimensions (width) compatible with endoscopic access, but may not preclude open surgical use. It is a thin metal housing that contains motor mating connectors and electronic communication interfaces. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521845497	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K240881	000

Device Sizes

Type	Value	Unit	Text
Length	30	Centimeter
Device Size Text, specify			XL;

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 55 – 101 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 55 – 101 KiloPascal