FDA.reportPublic FDA data

BOVIE

Primary DI
00607151056407
Brand
BOVIE
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
ES40
Catalog number
ES40
Device description
"EXTENDED MODIFIED NEEDLE BLADE ELECTRODE 6'' (15.24CM) 0.75""' (1.90CM)"
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
10607151056404PackageGS125In Commercial Distribution
00607151056407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060715105640410607151056404
00607151056407006071510564076071510564070607151056407

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

Contacts#

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

Regulatory Flags#

DUNS number
027680821
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

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
10887482177737BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177782BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177829BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177867BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177904BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177942BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177966BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177980BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178000BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178024BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178048BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
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