10K

Basic Information

• Brand Name: 10K
• Primary DI: 20845854041106
• Version / Model: 10K
• Catalog Number: 10K
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: 82c3bf50-1324-4b8c-8268-85da9f8e81d0
• Distribution End Date: 2023-10-11

Device Description

IRRIGATION CONSOLE 10K

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRX	Arthroscope	Orthopedic	888.1100	2
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36003	Arthroscopic irrigation/insufflation system	A mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	30845854041103	GS1
Primary	20845854041106	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -4 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 20 – 70 Degrees Celsius