ClearFit Posterior Fossa Plate

GUDID 00855113008579

ClearFit Posterior Fossa Plate

LONGEVITI NEURO SOLUTIONS LLC

Cranial resinous compound
Primary Device ID00855113008579
NIH Device Record Key8d773aaa-97c2-43b1-8048-e01cc98f8073
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearFit Posterior Fossa Plate
Version Model Number171731
Company DUNS070659539
Company NameLONGEVITI NEURO SOLUTIONS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855113008579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-27
Device Publish Date2025-02-19

Devices Manufactured by LONGEVITI NEURO SOLUTIONS LLC

00855113008579 - ClearFit Posterior Fossa Plate2025-02-27ClearFit Posterior Fossa Plate
00855113008579 - ClearFit Posterior Fossa Plate2025-02-27 ClearFit Posterior Fossa Plate
00855113008586 - ClearFit Retrosigmoid Large2025-02-27 ClearFit Retrosigmoid Large
00855113008753 - ClearFit Retrosigmoid Small2025-02-27 ClearFit Retrosigmoid Small
00860003416303 - ClearFit VDI Standard2025-02-27 ClearFit VDI Standard
00860003416310 - ClearFit VDI Large2025-02-27 ClearFit VDI Large
00855113008166 - ClearFit2024-11-28 ClearFit small for international sales
00855113008173 - ClearFit2024-11-28 ClearFit medium for international sales
00855113008197 - ClearFit2024-11-28 ClearFit X-Large for international sales

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