Edge

Basic Information

• Brand Name: Edge
• Primary DI: 10884521539747
• Version / Model: SD300BAPK
• 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: 2021-10-14
• Public Version Status: Update
• Public Device Record Key: cfdbb322-d8bc-4b8c-8ec3-0be091e38f69

Device Description

Bronchoscope Adapter;For use with Olympus bronchoscopes

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
62145	Endoscopic biopsy valve, single-use	A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521539744	GS1	CASE	10	In Commercial Distribution
Primary	10884521539747	GS1

Customer Contacts

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

Storage Conditions

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