NA

Basic Information

• Brand Name: NA
• Primary DI: 30653404049930
• Version / Model: 130187
• Catalog Number: 130187
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-09-06
• Public Version Status: Update
• Public Device Record Key: 5dbc29e4-de07-4826-854a-913f778fad61
• Distribution End Date: 2021-09-04

Device Description

ELECTROSURGICAL SUCTION COAGULATOR 10FR

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
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. 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	30653404049930	GS1
Unit of Use	00653404049939	GS1
Package	20653404049933	GS1	CARTON	25	Not in Commercial Distribution	2021-09-04

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033003	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 100 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -29 – 38 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 100 – 131 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 38 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 5 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 0 – 20 Percent (%) Relative Humidity