FDA UDI
In Commercial Distribution
🇺🇸 United States
RONDO'
DI: 08032909622214
·
Model: Screw ø3mm L16mm
·
CITIEFFE SRL
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RONDO'
- Primary DI
- 08032909622214
- Version / Model
- Screw ø3mm L16mm
- Catalog Number
- VP-13016
- Company Name
- CITIEFFE SRL
- Labeler DUNS
- 431406875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-21
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- c2f9563b-628c-4029-91c9-9bbdfb829d3b
Device Description
Titanium cannulated screw ø3mm L16mm with washer. 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
- 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 |
|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | 888.3030 | 2 |
| HTY | Pin, Fixation, Smooth | Orthopedic | 888.3040 | 2 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46646 | Orthopaedic bone screw, non-bioabsorbable, sterile | A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08032909622214 | GS1 |
Customer Contacts
- Phone
- +39051721850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113388 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Millimeter | |
| Outer Diameter | 3 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and clean environment and avoid damaging the packing. Room temperature.