FDA.reportPublic FDA data

Valleylab

Primary DI
00840113244348
Brand
Valleylab
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
E16514
Catalog number
E16514
Device description
Valleylab Micro Needle, 4.0”
Published
2026-05-04
Public version status
New
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
00840113244348PrimaryGS10
00840113243075Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113244348008401132443488401132443480840113244348
00840113243075008401132430758401132430750840113243075

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/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 single-use device intended to be used in a sterile condition.

Contacts#

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

Regulatory Flags#

DUNS number
027680821
Device count
10
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
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26
10607151008946BovieIDS-310IDS-3102016-10-13

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