Valleylab

Basic Information

• Brand Name: Valleylab
• Primary DI: 10884521194281
• Version / Model: CVPLP2000
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-01-30
• Public Version Status: Update
• Public Device Record Key: a3c7c5b3-4c91-4a1c-9c11-cc6fb75ce982

Device Description

Smoke Evacuation Pencil

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: No
• 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
Package	30884521194285	GS1	CASE	4	In Commercial Distribution
Primary	10884521194281	GS1
Package	20884521194288	GS1	PACK_OR_INNER_PACK	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103375	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry