PROFORMA

Basic Information

• Brand Name: PROFORMA
• Primary DI: 20653405051241
• Version / Model: 050320
• Catalog Number: 050320
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-06-07
• Public Version Status: Update
• Public Device Record Key: 708a9cf6-ac3d-4144-8737-0a97c28d85f0
• Distribution End Date: 2022-06-06

Device Description

PROFORMA Cannula, Long Tapered Tip, Pre-Curved

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODD	Endoscopic retrograde cholangiopancreatography (ERCP) cannula	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16429	ERCP catheter, non-balloon, non-electrical, single-use	A non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10653405051244	GS1	BOX	3	Not in Commercial Distribution	2022-06-06
Primary	20653405051241	GS1
Unit of Use	00653405051247	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K950700	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.89	Millimeter
Device Size Text, specify			1.7 Millimeter Catheter Gauge Diameter
Catheter Gauge	5	French
Length	200	Centimeter
Outer Diameter	0.035	Inch