FDA UDI
In Commercial Distribution
🇺🇸 United States
ST.A.R. 90 F4
DI: 08056711928487
·
Model: HA cortical bone screw ø5mm L130-30mm
·
CITIEFFE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ST.A.R. 90 F4
- Primary DI
- 08056711928487
- Version / Model
- HA cortical bone screw ø5mm L130-30mm
- Catalog Number
- ST550131HA
- Company Name
- CITIEFFE SRL
- Labeler DUNS
- 431406875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-12
- Public Version
- 1
- Public Version Date
- 2022-10-20
- Public Version Status
- New
- Public Device Record Key
- 557166fd-1a20-4da2-a1cf-8e5605c3c0b1
Device Description
Cortical bone screw with hydroxyapatite coating ø5mm L130mm - Thread L30mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609).
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| JDW | Pin, Fixation, Threaded | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48011 | External orthopaedic fixation system, single-use | An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056711928487 | GS1 |
Customer Contacts
- Phone
- +39051721850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150661 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 130 | Millimeter | |
| Outer Diameter | 5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and clean environment and avoid damaging the packing. Room temperature.