DEVICE: BOVIE (10607151006041)

Device Identifier (DI) Information

BOVIE
ESPR-EL
In Commercial Distribution
ESPR-EL
BOVIE MEDICAL CORPORATION
10607151006041
GS1

1
079940465 *Terms of Use
ELECTROSURGICAL HANDCONTROL PENCIL (BUTTON TYPE) WITH 1/16" COLLET (TOP 25)
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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?
61870 Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
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

d9e2631e-2fbc-4962-b6f9-b6502467f3ca
April 05, 2018
1
March 05, 2018
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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