OSSDSIGN Cranial PSI

GUDID 07350086550085

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)

Ossdsign AB

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable
Primary Device ID07350086550085
NIH Device Record Key484c4349-9232-4913-90c3-90107fbf1f12
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSDSIGN Cranial PSI
Version Model NumberS
Company DUNS350354370
Company NameOssdsign AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350086550085 [Primary]
GS117350086550082 [Package]
Package: Box [1 Units]
In Commercial Distribution

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-23
Device Publish Date2017-05-11

On-Brand Devices [OSSDSIGN Cranial PSI]

17350086550112OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cra
07350086550108OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cra
07350086550092OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cra
07350086550085OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cra

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