Signia

Basic Information

• Brand Name: Signia
• Primary DI: 10884521543799
• Version / Model: SIGPSHELL
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-08
• Public Version: 5
• Public Version Date: 2023-05-23
• Public Version Status: Update
• Public Device Record Key: e7693ab4-f1b4-4f6b-b3e8-329c20cd1834

Device Description

Power Shell

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: Yes
• 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
62382	Surgical stapler handpiece housing	A sterile casing designed to fit over the handpiece of a surgical stapler to create an aseptic barrier between the handpiece and the surgeon/sterile field whilst allowing full control of the stapler. It does not include any electrical controls. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521543796	GS1	CASE	6	In Commercial Distribution
Primary	10884521543799	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160176	000