PENADAPT

Basic Information

• Brand Name: PENADAPT
• Primary DI: 20845854080778
• Version / Model: PA2010
• Catalog Number: PA2010
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 3
• Public Version Date: 2023-09-04
• Public Version Status: Update
• Public Device Record Key: e7c25dd9-cceb-44a0-949d-4f39e299a2e8

Device Description

PenAdapt Electrosurgical Pencil Adapter 10 ft (30.5 m) tubing

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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYD	APPARATUS, EXHAUST, SURGICAL	General, Plastic Surgery	878.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30845854080775	GS1	Box	10	In Commercial Distribution
Primary	20845854080778	GS1
Unit of Use	00845854080774	GS1
Previous	00851136002143	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230547	000