FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OSSDSIGN Cranioplug
DI: 07350086550252
·
Model: 11 mm, 6 fixation-points
·
Ossdsign AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OSSDSIGN Cranioplug
- Primary DI
- 07350086550252
- Version / Model
- 11 mm, 6 fixation-points
- Company Name
- Ossdsign AB
- Labeler DUNS
- 350354370
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-05
- Public Version
- 6
- Public Version Date
- 2024-02-06
- Public Version Status
- Update
- Public Device Record Key
- 60af97f6-bdb6-4914-a3cd-f247cc6d919c
- Distribution End Date
- 2022-12-31
Device Description
OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GXR | Cover, Burr Hole | Neurology | 882.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46642 | Craniofacial fixation plate, non-bioabsorbable, non-customized | A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17350086550259 | GS1 | Box | 10 | Not in Commercial Distribution | 2022-12-31 |
| Primary | 07350086550252 | GS1 | ||||
| Package | 27350086550256 | GS1 | Envelope | 1 | Not in Commercial Distribution | 2022-12-31 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 fixation-points | ||
| Outer Diameter | 11 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 93 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 34 Degrees Celsius