DEVICE: DIEGO ELITE (00821925040670)

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Device Record History
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Device Identifier (DI) Information
DIEGO ELITE
TS102SF
In Commercial Distribution

Gyrus ACMI, LLC
00821925040670
GS1

1
007198742 *Terms of Use
TUBESET WITH FILTER FOR SUCTION MODULE DIEGO ELITE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

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
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K123429 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 25 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ab2fbb84-4c06-4be4-8221-862984d39ede
September 02, 2024
6
October 06, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00821925027831 5 00821925040670 In Commercial Distribution
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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