Artisential Monopolar Spatula

Basic Information

• Brand Name: Artisential Monopolar Spatula
• Primary DI: 08800042700805
• Version / Model: AMT01S-F
• Company Name: LIVSMED
• Labeler DUNS: 688360116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-22
• Public Version: 2
• Public Version Date: 2020-07-03
• Public Version Status: Update
• Public Device Record Key: 6af692a2-d7be-4c8b-ac0a-4e20ce92dee7

Device Description

Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscopic procedure

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800042700805	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200501	000

Device Sizes

Type	Value	Unit	Text
Shaft Length	25	Centimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius