Cranitomy Kit Disposable Low Speed

Basic Information

• Brand Name: Cranitomy Kit Disposable Low Speed
• Primary DI: 00810607000347
• Version / Model: 400-112
• Catalog Number: 400-112
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 64d79c4f-a54b-4408-9be1-933dd123ee78

Device Description

Cranitomy Kit Consisting of Qty 1 - D810607000101 Cranial Perforator Catalog# 200-331, QTY 1 - DI810607000392 Cranial Blade Catalog# 800-130 & QTY 1 -DI 810607000422 Wire Pass Drill Catalog# 800-330.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810607000347	GS1

Customer Contacts

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