CONMED

Basic Information

• Brand Name: CONMED
• Primary DI: 10653405008903
• Version / Model: 60-2121-001
• Catalog Number: 60-2121-001
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-11-30
• Public Version Status: Update
• Public Device Record Key: ff9c4bdb-b1e9-4f0b-abee-c3f0f6403cd8

Device Description

TUR/ENDOSCOPIC CABLE, 10' (3.05M)

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: Ethylene Oxide

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
61873	Endoscopic electrosurgical electrode, bipolar, reusable	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20653405008900	GS1	BOX	50	In Commercial Distribution
Primary	10653405008903	GS1
Unit of Use	00653405001952	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K831291	000

Device Sizes

Type	Value	Unit	Text
Length	10	Feet
Length	3.05	Meter

Storage Conditions

• 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
• Type: Handling Environment Humidity
• Temperature Range: High: 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -34 – 65 Degrees Celsius