PFS900000-00-00

GUDID 18054188160611

Patient specific cranial/craniofacial implant in hydroxyapatite ( US commercial name CustomizedBone Service)

FINCERAMICA FAENZA SPA

Cranial bone prosthesis, custom-made Cranial bone prosthesis, custom-made Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis

• Primary Device ID: 18054188160611
• NIH Device Record Key: 9af548ff-1d64-49ec-b30e-1f5bcb6f1bcb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PFS900000-00-00
• Catalog Number: PFS900000-00-00
• Company DUNS: 442706875
• Company Name: FINCERAMICA FAENZA SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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 -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054188160611 [Primary]

FDA Product Code

• PJN: Filler, Bone Void, Nonalterable Compound For Cranioplasty

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: 2018-07-12
• Device Publish Date: 2017-03-06