DEVICE: Bovie (10887482179366)

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Device Record History
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Device Identifier (DI) Information
Bovie
ESP6TN
Not in Commercial Distribution

ASPEN SURGICAL PRODUCTS, INC.
10887482179366
GS1
July 21, 2025
1
027680821 *Terms of Use
Electrosurgical Rocker Pencil With Coated Needle 50/Bx
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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?
61869 Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
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 single-use device intended to be used in a sterile condition.
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 [?]
K936304 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d20a6325-5c45-44db-8a8f-dcab374dcdee
October 29, 2025
3
August 28, 2024
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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
00887482179376 50 10887482179366 2025-07-21 Not in Commercial Distribution
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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