DEVICE: APOLLO (20653405051630)

Download: XML | JSON

Device Identifier (DI) Information

APOLLO
007100
007100
Conmed Corporation
20653405051630
GS1
1
APOLLO Papillotome, Double Lumen, 8mm Tapered Tip/20mm Monofilament Cutting Wire
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KNS Unit, electrosurgical, endoscopic (with or without accessories)
CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 32 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 20 Millimeter Cutting wire Length
Device Size Text, specify: 8 Millimeter Tip Length
Device Size Text, specify: 2.3 - 1.7 Millimeter Catheter Gauge Outer Diameter
Device Size Text, specify: 7 - 5 French Catheter Gauge Outer Diameter
Outer Diameter: 0.035 Inch
Outer Diameter: 0.889 Millimeter
CLOSE

Device Status

In Commercial Distribution
September 24, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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