FDA.reportPublic FDA data

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 1

Primary DI
00858736006168
Brand
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 1
Company
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
Model
7013-8051
Catalog number
7013-8051
Device description
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 1
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091107000MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEMHemostatix Medical Technologies, LLC2009-05-01GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858736006168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858736006168008587360061688587360061680858736006168

GMDN Terms#

Term, Definition table
TermDefinition
Haemostatic knifeA hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(901)261-0012customerservice@hemostatix.com

Regulatory Flags#

DUNS number
791221265
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858736006083HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5812 BLADE7023-58127023-58122019-04-11
00858736006090HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE7013-90507013-90502019-04-11
00858736006106HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE7023-90507023-90502019-04-11
00858736006113HEMOSTATIX THERMAL SCALPEL SYSTEM HANDLE7023-58157023-58152019-04-11
00858736006120HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE7013-58157013-58152019-04-11
00858736006144HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 BLADE7023-58107023-58102019-04-11
00858736006151HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 Blade7013-58107013-58102019-04-11
00858736006007HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH7013-84107013-84102016-08-02
00858736006014HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER7013-84007013-84002016-08-02
00858736006021HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8050 HANDLE - QTY 17013-80507013-80502016-08-02
00858736006038HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 107023-57157023-57152016-08-02
00858736006045HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 247013-57157013-57152016-08-02
00858736006052HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 107023-57107023-57102016-08-02
00858736006069HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 247013-57107013-57102016-08-02
00858736006076HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5712 BLADE - QTY 107023-57127023-57122016-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCGEI2026-06-03
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02