FDA.reportPublic FDA data

ClearFit

Primary DI
00855113008036
Brand
ClearFit
Company
LONGEVITI NEURO SOLUTIONS LLC
Model
171713
Catalog number
171713
Device description
Extra Large 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
10855113008033PackageGS12In Commercial Distribution
00855113008036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085511300803310855113008033
00855113008036008551130080368551130080360855113008036

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
00855113008043ClearFit1717141717142018-11-21
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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