ROSPITAL PRODUCTOS MEDICOS

Basic Information

• Brand Name: ROSPITAL PRODUCTOS MEDICOS
• Primary DI: 00812460024799
• Version / Model: ESPWH
• Catalog Number: ESPWH
• Company Name: ATLAS MEDICAL PRODUCTS LLC
• Labeler DUNS: 013112308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-23
• Public Version: 1
• Public Version Date: 2024-09-02
• Public Version Status: New
• Public Device Record Key: dd3bf922-2c00-41de-a526-7a39d2260351

Device Description

ELECTROSURGICAL PENCIL, STERILE, WHITE, W/HOLDER EA 50 PCS/BOX. 100PCS/CASE

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61869	Open-surgery electrosurgical handpiece/electrode, monopolar, single-use	A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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	00812460024799	GS1
Package	10812460024796	GS1	INNER	50	In Commercial Distribution
Package	20812460024793	GS1	CASE	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170369	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			ELECTROSURGICAL PENCIL, STERILE, WHITE, W/HOLDER EA 50 PCS/BOX. 100PCS/CASE