DEVICE: POWER POINT PLUS (30653405041096)

Device Identifier (DI) Information

POWER POINT PLUS
130384
Not in Commercial Distribution
130384
Conmed Corporation
30653405041096
GS1
March 07, 2017
10
071595540 *Terms of Use
POWER POINT PLUS ELECTROSURGICAL HANDPIECE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Open-surgery electrosurgical electrode, monopolar, reusable An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K936075 000
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Sterilization

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

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Storage and Handling
Storage Environment Humidity: between 5 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Humidity: between 0 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Length: 3 Meter
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Device Record Status

fa096ec4-b050-499f-922e-aff463703e2b
July 06, 2018
3
September 27, 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
20653405041099 10 30653405041096 2017-03-07 Not in Commercial Distribution CARTON
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Secondary DI

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

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Unit of Use DI Number: 00653405041095 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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