Intersept®

Basic Information

• Brand Name: Intersept®
• Primary DI: 00673978555560
• Version / Model: 7260
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-09
• Public Version: 4
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 4b0eafe4-36fb-4c98-a370-ff9ca2c812ab

Device Description

FILTER 7260 MEDTRONIC O2 STERILE 25PK

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRD	Device, Vascular, for Promoting Embolization	Cardiovascular	870.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35541	Spinal rongeur	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20673978555564	GS1	PK	25	In Commercial Distribution
Primary	00673978555560	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K882136	000