FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 18054188160611
·
Model: PFS900000-00-00
·
FINCERAMICA FAENZA SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 18054188160611
- Version / Model
- PFS900000-00-00
- Catalog Number
- PFS900000-00-00
- Company Name
- FINCERAMICA FAENZA SPA
- Labeler DUNS
- 442706875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-06
- Public Version
- 4
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- 9af548ff-1d64-49ec-b30e-1f5bcb6f1bcb
Device Description
Patient specific cranial/craniofacial implant in hydroxyapatite ( US commercial name CustomizedBone Service)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJN | Filler, Bone Void, Nonalterable Compound For Cranioplasty | Neurology | 882.5330 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | 882.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58908 | Custom-made cranial bone prosthesis | An 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18054188160611 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius