APOLLO 050063

GUDID 20653405051722

APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Monofilament Cutting Wire

Conmed Corporation

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 20653405051722
• NIH Device Record Key: 8a2d4874-3e49-42c7-9bb1-83cde29c339d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOLLO
• Version Model Number: 050063
• Catalog Number: 050063
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.889 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20653405051722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982557

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

[20653405051722]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [APOLLO]

• 00653405051681: APOLLO Papillotome
• 20653405051722: APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Monofilament Cutting Wire
• 20653405051715: APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/30mm Monofilament Cutting Wire
• 20653405051678: APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Braided Cutting Wire
• 20653405051661: APOLLO Papillotome, Double Lumen, 20mm Tapered Tip/30mm Monofilament Cutting Wire
• 20653405051654: APOLLO Papillotome, Double Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire
• 20653405051647: APOLLO Papillotome, Double Lumen, 8mm Tapered Tip/30mm Monofilament Cutting Wire
• 20653405051630: APOLLO Papillotome, Double Lumen, 8mm Tapered Tip/20mm Monofilament Cutting Wire
• 20653405051623: APOLLO AC PAPILLOTOME
• 20653405051616: APOLLO AC PAPILLOTOME
• 20653405051609: APOLLO PAPILLOTOME
• 20653405051593: APOLLO PAPILLOTOME
• 20653405051548: APOLLO AC PAPILLOTOME
• 20653405051531: APOLLO AC PAPILLOTOME