DEVICE: Henry Schein (00304040007303)

Device Identifier (DI) Information

Henry Schein
1127178
In Commercial Distribution
1127178
HENRY SCHEIN, INC.
00304040007303
GS1

1
012430880 *Terms of Use
LOOP TIP HIGH TEMP CAUTER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

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
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.
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FDA Product Code

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Product Code Product Code Name
HQP UNIT, CAUTERY, THERMAL, BATTERY-POWERED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121441 000
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Sterilization

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

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

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Size Type Text
No Device Sizes
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Device Record Status

1b780e8e-1d0d-4031-9762-817532330968
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
10304040007300 10 00304040007303 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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