NA

Basic Information

• Brand Name: NA
• Primary DI: 00845384002680
• Version / Model: IMRI-SHORT-HD
• Catalog Number: IMRI-SHORT-HD
• Company Name: Anspach Effort, The
• Labeler DUNS: 079116867
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-05
• Public Version: 5
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: f4d701cc-efa2-4076-aa3a-8718835392f5
• Distribution End Date: 2022-05-20

Device Description

5 cm Heavy Duty Short Attachment. Use with iMRI System Only

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: MR Conditional
• Direct Marking Exempt: No
• 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
HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	Neurology	882.4310	2
HBB	MOTOR, DRILL, PNEUMATIC	Neurology	882.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43555	Burring power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845384002680	GS1

Customer Contacts

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