FDA.reportPublic FDA data

ClearFit

Primary DI
00855113008043
Brand
ClearFit
Company
LONGEVITI NEURO SOLUTIONS LLC
Model
171714
Catalog number
171714
Device description
Complex Static Cranial Implant (Primary and Backup)
Published
2018-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable
PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2
PJNFiller, Bone Void, Non-Alterable Compound For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170410000Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC2018-03-23GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855113008040PackageGS12In Commercial Distribution
00855113008043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085511300804010855113008040
00855113008043008551130080438551130080430855113008043

GMDN Terms#

Term, Definition table
TermDefinition
Cranial resinous compoundA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area60Square centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Percent (%) Relative Humidity86 Percent (%) Relative Humidity
Special Storage Condition, Specify00See special handling instructions
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
410-527-1803info@longeviti.com

Regulatory Flags#

DUNS number
070659539
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855113008722ClearFit1717382024-03-20
00855113008005ClearFit1717101717102018-11-21
00855113008012ClearFit1717111717112018-11-21
00855113008029ClearFit1717121717122018-11-21
00855113008036ClearFit1717131717132018-11-21
00855113008166ClearFit9917102024-11-20
00855113008173ClearFit9917112024-11-20
00855113008197ClearFit9917132024-11-20
00855113008746ClearFit9917122024-11-20
00855113008579ClearFit Posterior Fossa Plate1717312025-02-19
00855113008586ClearFit Retrosigmoid Large1717342025-02-19
00855113008753ClearFit Retrosigmoid Small1717332025-02-19
00860003416303ClearFit VDI Standard1717162025-02-19
00860003416310ClearFit VDI Large1717182025-02-19
00855113008739ClearFit9917142024-11-20
00855113008715ClearFit1717372024-03-20
00855113008562ClearFit1717172024-03-15
00855113008623ClearFit1717192024-03-15
00855113008630Longeviti Convenience Kit 2.07000722024-03-15
00855113008647Longeviti Convenience Kit 3.07000732024-03-15

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