CONMED

Basic Information

• Brand Name: CONMED
• Primary DI: 30653404046687
• Version / Model: 138652A
• Catalog Number: 138652A
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: b3e2dc1a-265e-4d20-8f58-5f587428dab4
• Distribution End Date: 2018-06-25

Device Description

CONMED GOLDLINE FOOT CONTROLLED WITH NEEDLE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) CABLE, ELECTROSURGICAL HANDPIECE

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
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	20653404046680	GS1	CARTON	40	Not in Commercial Distribution	2018-06-25
Primary	30653404046687	GS1
Unit of Use	00653404046686	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	3	Meter
Length	10	Feet

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -34 – 65 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 5 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius