Cranial COVER “14 mm / 13 mm”

Basic Information

• Brand Name: Cranial COVER “14 mm / 13 mm”
• Primary DI: 08437006085076
• Version / Model: FC050300
• Company Name: NEOS SURGERY SL
• Labeler DUNS: 465890437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-11
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8103ff2b-2484-41cb-a7c7-de3accf79977

Device Description

Burr Hole Cover

Device Characteristics

• Single Use: Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXR	Cover, Burr Hole	Neurology	882.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15749	Cranial bur hole cover	A sterile device used to cover or to plug holes drilled into the skull during surgery and to reattach cranial bone removed during the intervention. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437006085076	GS1
Package	28437006085070	GS1		64	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160739	000