DEVICE: Henry Schein (00304040004814)

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Device Record History
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Device Identifier (DI) Information
Henry Schein
9004238
In Commercial Distribution
9004238
HENRY SCHEIN, INC.
00304040004814
GS1

2
012430880 *Terms of Use
Electrodes E10B
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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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?
44776 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 inert gas-enhanced electrosurgery.
Active false
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FDA Product Code

[?]
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
No
No
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
3f8ca5e0-4f61-45c5-859e-9eaac97e7bc3
April 04, 2023
4
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: 10304040004811 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
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No
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Customer Contact

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No Customer Contact currently defined
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