APOLLO3 007106

GUDID 00653405051575

APOLLO3 Papillotome, Triple Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire

Conmed Corporation

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 00653405051575
• NIH Device Record Key: 4f169148-3503-46b0-88d3-255d43c956ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOLLO3
• Version Model Number: 007106
• Catalog Number: 007106
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 0.889 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.035 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405051575 [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

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

Ethylene Oxide

[00653405051575]

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 [APOLLO3]

• 00653405051582: APOLLO3 Papillotome, Triple Lumen, 20mm Tapered Tip/30mm Monofilament Cutting Wire
• 00653405051575: APOLLO3 Papillotome, Triple Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire
• 00653405051568: APOLLO3 Papillotome, Triple Lumen, 8mm Tapered Tip/30mm Monofilament Cutting Wire
• 00653405051551: APOLLO3 Papillotome, Triple Lumen, 8mm Tapered Tip/20mm Monofilament Cutting Wire
• 10653405051565: APOLLO3 Papillotome, Triple Lumen, Monofilament Cutting Wire
• 10653405051558: APOLLO3 Papillotome, Triple Lumen, Monofilament Cutting Wire