FDA.reportPublic FDA data

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER

Primary DI
00858736006014
Brand
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER
Company
HEMOSTATIX MEDICAL TECHNOLOGIES LLC
Model
7013-8400
Catalog number
7013-8400
Device description
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER
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
00858736006014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858736006014008587360060148587360060140858736006014

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

Contacts#

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

Regulatory Flags#

DUNS number
791221265
Device count
1
Serial number
true
Manufacturing date on label
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
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
00858736006168HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 17013-80517013-80512016-08-02

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