Signia

Basic Information

• Brand Name: Signia
• Primary DI: 10884521543874
• Version / Model: SIGRIG
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-31
• Public Version: 4
• Public Version Date: 2023-05-23
• Public Version Status: Update
• Public Device Record Key: 416102e1-ac30-498d-8f8b-f38a99a7f385

Device Description

Reusable Insertion Guide

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
60486	Surgical instrument battery insertion guide	A non-sterile device intended to protect a sterile, battery-powered surgical instrument during insertion of a non-sterile battery such that the sterility of the surgical instrument is maintained; it may be intended for use preoperatively and/or during surgery. It is typically a shaped template which is designed to fit and cover the profile of the battery insertion port. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521543874	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160176	000