Hobbs Medical TouchSoft Coagulator 4581-U

GUDID M849G11200400

An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).

HOBBS MEDICAL, INC.

Argon-enhanced endoscopic electrosurgical electrode, reusable

• Primary Device ID: M849G11200400
• NIH Device Record Key: 7e99beba-c485-46b2-a500-4b4dca609f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hobbs Medical TouchSoft Coagulator
• Version Model Number: GS1120040
• Catalog Number: 4581-U
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M849G11200400 [Primary]
HIBCC	M849G11200401 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093079

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without 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: 2021-04-15
• Device Publish Date: 2021-04-07

Devices Manufactured by HOBBS MEDICAL, INC.

• M84960010 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960020 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960030 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960040 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960230 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960240 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960270 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.
• M84960280 - Hobbs Biliary Pigtail Stent Kit: 2024-08-30 Biliary Pigtail Stent Kit includes Stent, Guide Wire, Push Catheter and Guide Catheter.