FDA.reportPublic FDA data

Bovie

Primary DI
00887482178096
Brand
Bovie
Company
SYMMETRY SURGICAL INC.
Model
ES18
Device description
Blade Electrode 45 Deg 5/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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482178096PackageGS15In Commercial Distribution
10887482178086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482178096008874821780968874821780960887482178096
1088748217808610887482178086

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

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
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693362MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693379MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693454MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693461MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693478MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693485MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10