HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER 7013-8400

GUDID 00858736006014

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER

HEMOSTATIX MEDICAL TECHNOLOGIES LLC

Haemostatic knife

• Primary Device ID: 00858736006014
• NIH Device Record Key: ec26f5ad-cd14-4ab2-9e18-a9112db6ba24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER
• Version Model Number: 7013-8400
• Catalog Number: 7013-8400
• Company DUNS: 791221265
• Company Name: HEMOSTATIX MEDICAL TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(901)261-0012
• Email: customerservice@hemostatix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858736006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091107

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-02

Devices Manufactured by HEMOSTATIX MEDICAL TECHNOLOGIES LLC

• 00858736006083 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5812 BLADE: 2019-04-19 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5812 BLADE
• 00858736006090 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE: 2019-04-19 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE
• 00858736006106 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE: 2019-04-19 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE
• 00858736006113 - HEMOSTATIX THERMAL SCALPEL SYSTEM HANDLE: 2019-04-19 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5815 BLADE
• 00858736006120 - HEMOSTATIX THERMAL SCALPEL SYSTEM BLADE: 2019-04-19 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5815 BLADE
• 00858736006144 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 BLADE: 2019-04-19 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 BLADE
• 00858736006151 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 Blade: 2019-04-19 HEMOSTATIX THERMAL SCALPEY SYSTEM MODEL 5810 BLADE
• 00858736006007 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH: 2018-07-06 HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH