ASSISTARM

Basic Information

• Brand Name: ASSISTARM
• Primary DI: 10845854043455
• Version / Model: AA-K600
• Catalog Number: AA-K600
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-28
• Public Version: 3
• Public Version Date: 2023-09-25
• Public Version Status: Update
• Public Device Record Key: 134b5288-d953-40eb-adbc-f1d14eeb81d5

Device Description

AssistArm Knee Attachment

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: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58984	Intraoperative freestanding patient positioning frame	A non-sterile device designed to support and stabilize a patient's arm or leg in a desired posture during a surgical procedure, typically an orthopaedic procedure where it is intended to be used with an arm or leg ring. It is typically in the form of a frame with a base and support arch that is not attached to a parent device (freestanding); it is typically constructed of plastic materials. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10845854043455	GS1
Direct Marking	20845854043452	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit