HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE 7013-9050

GUDID 00858736006090

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE

HEMOSTATIX MEDICAL TECHNOLOGIES LLC

Haemostatic knife

• Primary Device ID: 00858736006090
• NIH Device Record Key: 46e6d8ef-29d0-4b66-b7cb-d5a144027b4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE
• Version Model Number: 7013-9050
• Catalog Number: 7013-9050
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00858736006090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183009

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-19
• Device Publish Date: 2019-04-11

On-Brand Devices [HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE]

• 00858736006106: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE
• 00858736006090: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 9050 HANDLE