DEVICE: Bovie (10887482176853)

Device Identifier (DI) Information

Bovie
0003Y
In Commercial Distribution

SYMMETRY SURGICAL INC.
10887482176853
GS1

1
079641356 *Terms of Use
Neuro Pulse Yellow LED (10/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?
35724 Facial nerve-locating system
An assembly of devices designed to locate a facial nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. It typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge, electrical sensors), and audible and/or visual indicators. The system generates rectangular- and possibly triangular-waveform currents to stimulate nerve fibres and produce muscular contraction. It is used during diagnosis and assessment of nerve function, to locate nerves during surgery reducing the chance of accidental injury, and to monitor the progress of nerve regeneration after surgery.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ETN Stimulator, Nerve
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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

d813e193-b8e0-402a-8ec9-ed1f5670f137
June 04, 2025
2
August 27, 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
00887482176863 10 10887482176853 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

[?]
+1 888-364-7004
customerservice@symmetrysurgical.com
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