Edge

Basic Information

• Brand Name: Edge
• Primary DI: 10884521581388
• Version / Model: SDK4190-FT
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: ad921b83-12da-4574-8349-85dc3993b474

Device Description

Firm Tip; Endobronchial Procedure Kit;190 Catheter

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: Yes
• 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
JAK	System, x-ray, tomography, computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57786	Bronchoscopic catheter	A sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521581388	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1069.5	Millimeter
Outer Diameter	2.68	Millimeter
Device Size Text, specify			Second Outer Diameter,2.0,Millimeter;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry