N/A

Basic Information

• Brand Name: N/A
• Primary DI: H671DLPB050
• Version / Model: External Lesion Electrodes
• Catalog Number: DLP-B05
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2019-12-18
• Public Version Status: Update
• Public Device Record Key: ce6396c6-289e-4a7c-98d9-0fc09c128963

Device Description

Electrosurgical Loop Electrode, 25mm Wide X 8mm Deep, 5.5cm Shaft Length

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: Yes
• 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
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H671DLPB052	HIBCC	Overpack	10	In Commercial Distribution
Package	H671DLPB051	HIBCC	Box	10	In Commercial Distribution
Primary	H671DLPB050	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905263	000
K951032	000

Device Sizes

Type	Value	Unit	Text
Depth	8	Millimeter
Width	25	Millimeter