FDA.reportPublic FDA data

Bovie

Primary DI
00887482176863
Brand
Bovie
Company
SYMMETRY SURGICAL INC.
Model
0003Y
Device description
Neuro Pulse Yellow LED (10/bx)
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482176863PackageGS110In Commercial Distribution
10887482176853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482176863008874821768638874821768630887482176863
1088748217685310887482176853

GMDN Terms#

Term, Definition table
TermDefinition
Facial nerve-locating systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079641356
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887482014902Symmetry Surgical46-31772024-09-09
10887482014919Symmetry Surgical46-31782024-09-09
00887482155271Symmetry SurgicalSG52024-09-09
00887482155295Symmetry SurgicalSG102024-09-09
00887482155318Symmetry SurgicalTDSG52024-09-09
00887482155332Symmetry SurgicalTDSG102024-09-09
00887482154359Symmetry Surgical24-55002024-09-04
00887482154366Symmetry Surgical24-55012024-09-04
00887482154373Symmetry Surgical24-55022024-09-04
00887482154380Symmetry Surgical24-55112024-09-04
00887482154427Symmetry Surgical24-55122024-09-04
10887482012816Symmetry Surgical43-10302024-09-04
10887482012823Symmetry Surgical43-10322024-09-04
10887482154158Symmetry Surgical81-10022024-09-04
10887482154172Symmetry Surgical81-10062024-09-04
10887482154196Symmetry Surgical81-10102024-09-04
10887482154219Symmetry Surgical81-10112024-09-04
10887482154233Symmetry Surgical81-10122024-09-04
10887482154271Symmetry Surgical81-10002024-09-04
10887482154295Symmetry Surgical81-10012024-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
00887517413673MAS PLIFNuvasive, Inc.ETN2026-04-25
00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29
20199150023862N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023879N/AMEDTRONIC XOMED, INC.ETN2026-02-16
20199150023886N/AMEDTRONIC XOMED, INC.ETN2026-02-16
B006NVHS102NONENeurovision Medical Products, Inc.ETN2025-12-18
03662674000525PediGuard DSG ConnectSPINEGUARDETN2025-09-17
B006HGELS102NONENeurovision Medical Products, Inc.ETN2025-02-12
B006NVPS2Nerveäna+®Neurovision Medical Products, Inc.ETN2025-02-11
20763000842547Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842554Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
20763000842561Bipolar Stimulating ProbeMEDTRONIC XOMED, INC.ETN2024-10-26
10887482176853BovieASPEN SURGICAL PRODUCTS, INC.ETN2024-08-27
08720791376451Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376475Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791376482Technomed EuropeTechnomed Engineering B.V.ETN2024-05-06
08720791373634NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
08720791373665NeuroradiumTechnomed Engineering B.V.ETN2024-02-12
B006NVPMK1Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01
B006NVPSTST2Nerveäna+®Neurovision Medical Products, Inc.ETN2024-02-01