DEVICE: APOLLO (20653405051616)

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Device Record History
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Device Identifier (DI) Information
APOLLO
7100AC
Not in Commercial Distribution
7100AC
Conmed Corporation
20653405051616
GS1
June 07, 2022
1
071595540 *Terms of Use
APOLLO AC PAPILLOTOME
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61875 Endoscopic electrosurgical electrode, monopolar, single-use
A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNS Unit, electrosurgical, endoscopic (with or without accessories)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K982557 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between 15 and 27 Degrees Celsius
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Length: 5 Millimeter
Outer Diameter: 0.035 Inch
Device Size Text, specify: 7 - 4.5 French Catheter Gauge
Outer Diameter: 0.889 Millimeter
Device Size Text, specify: 2.3 - 1.5 Millimeter Catheter Gauge
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Device Record Status
e8883a0b-f55e-48e1-8ad7-d9d6c522aea7
June 08, 2022
4
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
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