Porges Coloplast

Basic Information

• Brand Name: Porges Coloplast
• Primary DI: 03600040226773
• Version / Model: DOR214
• Catalog Number: DOR214
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 25c1d46c-1bd8-4f12-be2d-764c52079cd1

Device Description

DORMIA® Stone extractor 4 CH/FR with an "extractible basket"

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: Yes
• 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
FFL	DISLODGER, STONE, BASKET, URETERAL, METAL	Gastroenterology, Urology	876.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44333	Urinary stone retrieval basket, single-use	A manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03600040226773	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	4	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store away from light in a cool and dry place