DEVICE: APOLLO (20653405051678)
Device Identifier (DI) Information
APOLLO
050053
Not in Commercial Distribution
050053
Conmed Corporation
050053
Not in Commercial Distribution
050053
Conmed Corporation
APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Braided Cutting Wire
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNS | Unit, electrosurgical, endoscopic (with or without accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K982557 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit |
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit |
Handling Environment Temperature: between 16 and 27 Degrees Celsius |
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit |
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 32 Degrees Celsius |
Handling Environment Temperature: between -29 and 60 Degrees Celsius |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 7 - 5.5 French Catheter Gauge Diameter |
Outer Diameter: 0.035 Inch |
Outer Diameter: 0.889 Millimeter |
Device Size Text, specify: 2.3 - 1.8 Millimeter Catheter Gauge Diameter |
Length: 20 Millimeter |
Length: 8 Millimeter |
Device Record Status
4536dda6-9539-4686-ac1f-11be225427ba
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
CUSTOMER_SERVICE@CONMED.COM