FDA.reportPublic FDA data

BOVIE

Primary DI
10607151006317
Brand
BOVIE
Company
BOVIE MEDICAL CORPORATION
Model
ES57
Catalog number
ES57
Device description
MODIFIED NEEDLE ELECTRODE 4'' (10.16CM)
Published
2016-10-07
Public version status
Update
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
HGIElectrocautery, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607151006317PackageGS125In Commercial Distribution
00607151006310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715100631710607151006317
00607151006310006071510063106071510063100607151006310

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079940465
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
false
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
00607151009854BovieE15646E156462020-11-16
00607151009861BovieE15644E156442020-11-16
00607151009878BovieE15596E155962020-11-16
00607151009885BovieE15606E156062020-11-16
00607151009892BovieE15616E156162020-11-16
00607151009908BovieE15626E156262020-11-16
00607151009915BovieE15594E155942020-11-16
00607151009922BovieE15604E156042020-11-16
00607151009939BovieE15614E156142020-11-16
00607151009946BovieE15624E156242020-11-16
00607151009953BovieE16512E165122020-11-16
00607151009960BovieE16514E165142020-11-16
10607151010796BOVIEBA3350ABA3350A2016-10-07
10607151010819BOVIEBA3390ABA3390A2016-10-07
10607151010826BOVIEBA3390NABA3390NA2016-10-07
10607151010833BOVIEBA3350NABA3350NA2016-10-07
10607151010840BOVIEBA2455NABA2455NA2016-10-07
10607151010857BOVIEBA1860NABA1860NA2016-10-07
10607151007604J-PLASMA® GS-270CGS-270C2016-09-21
10607151007819J-PLASMA® GS-018CGS-018C2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887482196646ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196653ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196707ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196714ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196721ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196738ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196745ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196752ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482177065BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177560BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177584BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177713BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
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10887482178062BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178123BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178161BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178208BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178222BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178246BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178260BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27