FDA UDI
In Commercial Distribution
🇺🇸 United States
DOLPHIX
DI: 08052990972500
·
Model: Transfixing bone screw ø6mm L200mm
·
CITIEFFE SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DOLPHIX
- Primary DI
- 08052990972500
- Version / Model
- Transfixing bone screw ø6mm L200mm
- Catalog Number
- DF416200
- Company Name
- CITIEFFE SRL
- Labeler DUNS
- 431406875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9badb371-6d57-4fe2-ad32-ac7fb2527a8e
Device Description
Transfixing bone screw ø6mm L200mm. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
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
- 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 |
|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 888.3030 | 2 |
| JDW | Pin, Fixation, Threaded | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48012 | External orthopaedic fixation system, single-use, sterile | An assembly of sterile devices designed to stabilize fractured bones of the lower limbs 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 and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052990972500 | GS1 |
Customer Contacts
- Phone
- +39051721850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163323 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 200 | Millimeter | |
| Outer Diameter | 6 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and clean environment and avoid damaging the packing. Room temperature.