OSSDSIGN Cranial PSI 101010

GUDID 07350086550108

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

• Primary Device ID: 07350086550108
• NIH Device Record Key: b512122c-cbf7-4ddf-8ee9-284b5bb73bc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSDSIGN Cranial PSI
• Version Model Number: L
• Catalog Number: 101010
• Company DUNS: 350354370
• Company Name: Ossdsign AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350086550108 [Primary]
GS1	17350086550105 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• GXN: Plate, Cranioplasty, Preformed, Non-Alterable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-23
• Device Publish Date: 2017-05-11

On-Brand Devices [OSSDSIGN Cranial PSI]

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