DEVICE: Monopolar High Frequency Cord Male to Female Connector (00801741077289)

Device Identifier (DI) Information

Monopolar High Frequency Cord Male to Female Connector
5601100
Not in Commercial Distribution
5601100
Davol Inc.
00801741077289
GS1
May 31, 2017
1
001191048 *Terms of Use
Monopolar High Frequency Cord Male to Female Connector
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Electrical-only medical device connection cable, reusable A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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 [?]
K911274 000
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 30 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ec101fd8-38db-4e96-88cb-b905e9b05423
July 06, 2018
3
February 22, 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
10801741077286 1 00801741077289 2017-05-31 Not in Commercial Distribution Other
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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: 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
No
No
No CLOSE

Customer Contact

[?]
+1(800)562-0027
medical.services@crbard.com
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