Eversense® Insertion Tools Kit

Basic Information

• Brand Name: Eversense® Insertion Tools Kit
• Primary DI: 00817491021397
• Version / Model: FG-8211-01-201
• Catalog Number: FG-8211-01-201
• Company Name: SENSEONICS, INCORPORATED
• Labeler DUNS: 966865636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-16
• Public Version: 3
• Public Version Date: 2019-11-27
• Public Version Status: Update
• Public Device Record Key: f6a52b70-e1cf-4b6f-9cfd-18c5153c4f40

Device Description

Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.

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: Yes
• 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
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use	Unknown		3
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61914	Subcutaneous implantation kit, non-medicated	A collection of devices intended to be used for the implantation of a subcutaneous device (e.g., implantable glucose sensor) [not included]. It typically consists of a blunt dissector, cannula and may include non-dedicated devices (e.g., dressings); it does not contain pharmaceutical components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817491021397	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160048	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit