PROFORMA

Basic Information

• Brand Name: PROFORMA
• Primary DI: 40653405051412
• Version / Model: 050906
• Catalog Number: 050906
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-06-06
• Public Version: 4
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 33c4af8a-e937-4e40-9ec0-5499e63e2a02

Device Description

PROFORMA HF 4.5 Cannula, Straight Taper Tip

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
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	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	50653405051419	GS1	BOX	5	In Commercial Distribution
Primary	40653405051412	GS1
Unit of Use	00653405051414	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050777	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			7 -5 FRENCH Catheter Diameter 1
Outer Diameter	0.89	Millimeter
Device Size Text, specify			1.7 MM Catheter Diameter
Device Size Text, specify			1.5 MM Catheter Diameter
Outer Diameter	0.035	Inch
Device Size Text, specify			4.5 French Catheter Diameter
Length	190	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 120 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 4 – 49 Degrees Celsius