APOLLO

Basic Information

• Brand Name: APOLLO
• Primary DI: 00653405051681
• Version / Model: 050054
• Catalog Number: 050054
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-04
• Public Version: 5
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 90e0212a-ee64-4741-b9ea-8042bf70c283
• Distribution End Date: 2020-10-21

Device Description

APOLLO Papillotome

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
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00653405051681	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982557	000

Device Sizes

Type	Value	Unit	Text
Length	8	Millimeter
Device Size Text, specify			2.3 - 1.8 Millimeter Catheter Outer Diameter
Length	30	Millimeter
Outer Diameter	0.035	Inch
Device Size Text, specify			7 - 5.5 French Catheter Outer Diameter
Outer Diameter	0.889	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 16 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit