ClearFit

Basic Information

• Brand Name: ClearFit
• Primary DI: 00855113008043
• Version / Model: 171714
• Catalog Number: 171714
• Company Name: LONGEVITI NEURO SOLUTIONS LLC
• Labeler DUNS: 070659539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-21
• Public Version: 1
• Public Version Date: 2018-12-24
• Public Version Status: New
• Public Device Record Key: 0546b7b3-13e2-4709-99bb-62b4102f3d07

Device Description

Complex Static Cranial Implant (Primary and Backup)

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	882.5330	2
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16131	Cranial resinous compound	A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855113008043	GS1
Package	10855113008040	GS1	Case	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170410	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	60	Square centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: See special handling instructions
• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 0 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit