Cranial LOOP

Basic Information

• Brand Name: Cranial LOOP
• Primary DI: 18437006085042
• Version / Model: FC050000
• Company Name: NEOS SURGERY SL
• Labeler DUNS: 465890437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7ded4938-0c7f-4805-a250-c9b981e4334d

Device Description

Cranial Fixation System

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
Package	48437006085043	GS1		10	In Commercial Distribution
Package	38437006085046	GS1		6	In Commercial Distribution
Primary	18437006085042	GS1
Package	28437006085049	GS1		64	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132044	000