FDA UDI
In Commercial Distribution
🇺🇸 United States
CranioFit
DI: M384CF260100070
·
Model: KT-T1L7H1
·
Bioplate, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CranioFit
- Primary DI
- M384CF260100070
- Version / Model
- KT-T1L7H1
- Catalog Number
- CF26010007
- Company Name
- Bioplate, Inc.
- Labeler DUNS
- 838734093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-10
- Public Version
- 2
- Public Version Date
- 2025-06-09
- Public Version Status
- Update
- Public Device Record Key
- 95a1f6cf-9fc6-4560-aa32-63b26b404eed
Device Description
CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | Neurology | 882.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46268 | Cranioplasty plate, non-alterable | An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M384CF260100070 | HIBCC |
Customer Contacts
- Phone
- 8882467528
- [email protected]