HNM Women Care

Basic Information

• Brand Name: HNM Women Care
• Primary DI: 00842962103371
• Version / Model: H-OB1010S
• Catalog Number: H-OB1010S
• Company Name: HNM STAINLESS, LLC.
• Labeler DUNS: 806754185
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-05-30
• Public Version: 3
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: 408bbc5e-70ce-45ca-bdf9-fdae32563d7c
• Distribution End Date: 2023-12-29

Device Description

DISPOSABLE SQUARE LOOP ELECTRODES, 10mm x 10mm, STERILE, BOX OF 5

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: 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

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
Primary	00842962103371	GS1
Unit of Use	00084296210039	GS1