FDA.reportPublic FDA data

DISPOSABLE SUPER CUT FINE NEEDLE

Primary DI
00192896009417
Brand
DISPOSABLE SUPER CUT FINE NEEDLE
Company
SONTEC INSTRUMENTS, INC.
Model
ES61HS
Catalog number
ES61HS
Device description
DISPOSABLE SUPER CUT TUNGSTEN CARBIDE MODIFIED FINE NEEDLE WITH HEAT SHRINK SET
Published
2018-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942986000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942986000ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)Aaron Medical Industries1995-03-21HGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896009417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896009417001928960094171928960094170192896009417

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
Length4.5Millimeter

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896123755Debakey-Diethrich Tissue Forceps442-239P442-239P2026-09-18
00192896123762TAVR Removal Set2400-200-SET2400-200-SET2026-09-18
00192896123779Waever Chalazion Forceps14-988014-98802026-09-18
00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
00192896123632Adson Dressing Forceps140-299S140-299S2026-08-27
00192896123649Converse Scissors460-156L460-156L2026-08-27
00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
00192896122499Cartilage Graft Cutter350-842350-8422025-11-21
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25
00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24
00192896123533Rochester Carmalt Forceps1100-152LQ1100-152LQ2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113242983VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
10840113242990VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
10840113243034VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
10840113243058VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
10840113243072VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
10840113243089VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
10840113243096VALLEYLAB™ASPEN SURGICAL PRODUCTS, INC.HGI2026-09-18
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
10887482178284BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27