FDA.reportPublic FDA data

NA

Primary DI
18054188160611
Brand
NA
Company
FINCERAMICA FAENZA SPA
Model
PFS900000-00-00
Catalog number
PFS900000-00-00
Device description
Patient specific cranial/craniofacial implant in hydroxyapatite ( US commercial name CustomizedBone Service)
Published
2017-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable
PJNFiller, Bone Void, Nonalterable Compound For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2
PJNFiller, Bone Void, Non-Alterable Compound For CranioplastyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054188160611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805418816061118054188160611

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bone prosthesis, custom-madeA sterile implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
442706875
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325594HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-25
00810188325679HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-24
00810188325624HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21
00810188325631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21
00810188325457HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-04
00810188325464HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-04
00810188325303HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26
00810188325372HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26
00810188325389HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26
00810188325327HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-19
00810188325334HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-19
00810188325297HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-17
00810188325259HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-07
00810188325266HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-07
00810188325044HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325204HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325174HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-31
00810188325129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-28
00810188325105HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-27
00810188325099HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325112HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13