Protege GPS

Basic Information

• Brand Name: Protege GPS
• Primary DI: 00821684031827
• Version / Model: SERB65-14-60-120
• Company Name: Covidien LP
• Labeler DUNS: 968903703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 5
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: ccb417ee-3eeb-495a-978e-ce59b42a41b6

Device Description

Self-Expanding Biliary Stent System

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43691	Bare-metal biliary stent	A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821684031827	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050725	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	14	Millimeter
Length	60	Millimeter
Device Size Text, specify			Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,11.5-13.0,Millimeter;
Catheter Gauge	6	French

Storage Conditions

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