DEVICE: Emprint HP (10884521813014)

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Device Record History
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Device Identifier (DI) Information
Emprint HP
CAGENHPZD
In Commercial Distribution

Covidien LP
10884521813014
GS1

1
058614483 *Terms of Use
Ablation Generator with Thermosphere (TM) Technology
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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?
40783 Microwave hyperthermia system
A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NEY SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K200796 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -22 and 140 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Power, 150, W;
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Device Record Status
9e2ce6e4-aff1-4d4b-997c-2e82ec6ff1f4
June 24, 2025
6
October 25, 2020
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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
No Package DIs found
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Secondary DI

[?]
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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