MACROLYTE

Basic Information

• Brand Name: MACROLYTE
• Primary DI: 30653405007269
• Version / Model: 425-2801
• Catalog Number: 425-2801
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2021-04-01
• Public Version Status: Update
• Public Device Record Key: a7201233-b17c-486d-9c2b-9fb03d8624df

Device Description

MACROLYTE PEDIATRIC DUAL DISPERSIVE ELECTRODE

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: No
• 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
58494	Electrosurgical return electrode, single-use	A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20653405007262	GS1	BOX	100	In Commercial Distribution
Primary	30653405007269	GS1
Unit of Use	00653405007268	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: High: 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 16 – 27 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity