AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04038653369980
• Version / Model: GA529
• Catalog Number: GA529
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2021-05-28
• Public Version Status: Update
• Public Device Record Key: 28e6c539-156c-4a89-8f52-f3eb42915698
• Distribution End Date: 2021-04-16

Device Description

HiLAN with hand control

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HBB	MOTOR, DRILL, PNEUMATIC	Neurology	882.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37876	Surgical power tool system handpiece, rotary, pneumatic	A hand-held, pneumatically-powered device intended to provide rotation for a rotary endpiece instrument during surgical procedures performed on bones and tough tissues (e.g., cartilage, ligaments). It typically has the capacity to be used with a variety of rotary instruments (e.g., drill bits, reamers, cutters) and is not dedicated to a specific clinical procedure. It includes a built-in motor and an attachment for direct connection of an endpiece(s) [which is not included]. The device may be cannulated to enable use of a guidewire and may be of the micro or macro design. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038653369980	GS1

Customer Contacts

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