DEVICE: Henry Schein (00304040007297)

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Device Record History
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Device Identifier (DI) Information
Henry Schein
1127177
In Commercial Distribution
1127177
HENRY SCHEIN, INC.
00304040007297
GS1

1
012430880 *Terms of Use
TIP HIGH TEMP CAUTERY
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
35029 Electrocautery system generator, battery-powered
A battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HQP UNIT, CAUTERY, THERMAL, BATTERY-POWERED
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
dbe2351d-3720-4ae8-806a-db87e5a0a45c
November 01, 2021
4
September 24, 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
10304040007294 10 00304040007297 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

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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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