NeuroPro® Low Profile

Basic Information

• Brand Name: NeuroPro® Low Profile
• Primary DI: 00898142001708
• Version / Model: 16-1P3-8915
• Catalog Number: 16-1P3-8915
• Company Name: Kinamed, Inc.
• Labeler DUNS: 184896645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-06
• Public Version: 3
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: a1aa01d4-d077-420c-96ad-b4544d128496

Device Description

Plate Panel, Heavy, 0.6mm

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: 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
GWO	Plate, cranioplasty, preformed, alterable	Neurology	882.5320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35651	Cranioplasty sheet	A flat piece of implantable metal (typically tantalum) designed to repair small cranial bone defects (i.e., cranioplasty). It is usually perforated and can be shaped to a desired contour using a mallet and a wood block and cut with shears to an appropriate dimension, intraoperatively. Prefabricated metallic plates, which may be manufactured from metallic sheets, are frequently used to repair larger cranial bone defects.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00898142001708	GS1