HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24

Basic Information

• Brand Name: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24
• Primary DI: 00858736006045
• Version / Model: 7013-5715
• Catalog Number: 7013-5715
• Company Name: HEMOSTATIX MEDICAL TECHNOLOGIES LLC
• Labeler DUNS: 791221265
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2016-08-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7313211d-63b3-4c69-b9a7-1f04f9a3261d

Device Description

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36136	Haemostatic knife	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858736006045	GS1
Unit of Use	00858736006137	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033089	000