DEVICE: Henry Schein (00304040004968)

Device Identifier (DI) Information

Henry Schein
9004253
In Commercial Distribution
9004253
HENRY SCHEIN, INC.
00304040004968
GS1

2
012430880 *Terms of Use
Electrodes E20AXL 90
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Electrosurgical system An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.
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FDA Product Code

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Product Code Product Code Name
EKZ UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052622 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 0.0625 Inch
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Device Record Status

9c935f8f-fabc-40ab-8380-faf1468e5884
July 06, 2018
3
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

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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: 10304040004965 CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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