Cranial Blade Disposable Low Speed

Basic Information

• Brand Name: Cranial Blade Disposable Low Speed
• Primary DI: 00810607000385
• Version / Model: 800-130 Single
• Catalog Number: 800-130 Single
• Company Name: ACRA-CUT INC
• Labeler DUNS: 612611459
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9e468b39-e274-43d3-b666-706062fba860

Device Description

Cranial Blade Disposable Low Speed 800-130 Single, Straight Flute

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	882.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46272	Cranial trephine, single-use	A neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, e.g., for the insertion of a catheter or a neuroscope for diagnosis, or treatments such as, to alleviate intracranial pressure (ICP), obtain cerebrospinal fluid samples, inject radiopaque dyes. It may be used to make several holes for the removal of a bone flap. It is typically a hollow cylinder with a circular, saw-like serrated working edge and a centre drill for guidance. It is an exchangeable device, typically made of high-grade stainless steel, that is attached to a manually rotated handle or to a powered rotary surgical handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810607000385	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K911819	000