ASSISTO® Arm-System

Basic Information

• Brand Name: ASSISTO® Arm-System
• Primary DI: 14049679076735
• Version / Model: CA 301-20-01
• Catalog Number: CA 301-20-01
• Company Name: GEOMED Medizin-Technik GmbH & Co. KG
• Labeler DUNS: 316151174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-20
• Public Version: 3
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: 95e58613-b0ee-45fc-9031-1790b9a8e68e

Device Description

ASSISTO R310MM U-STAND 400X400X170MM WITH UNIVERSAL RETRACTOR HOLDER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
GWG	Endoscope, Neurological	Neurology	882.1480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62379	Surgical instrument assist arm system, manually-adjusted	A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14049679076735	GS1