FDA UDI
In Commercial Distribution
🇺🇸 United States
DINAMIC T HUMERUS
DI: 08052990972616
·
Model: ø2.5mmx450mm graduated guide wire (sterile)
·
CITIEFFE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DINAMIC T HUMERUS
- Primary DI
- 08052990972616
- Version / Model
- ø2.5mmx450mm graduated guide wire (sterile)
- Catalog Number
- DT070004
- Company Name
- CITIEFFE SRL
- Labeler DUNS
- 431406875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-17
- Public Version
- 4
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 6a8b88d2-3874-4552-b1e8-b209541ec0d1
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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62729 | Orthopaedic guidewire, single-use | A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052990972616 | GS1 |
Customer Contacts
- Phone
- +39051721850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113387 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and clean environment and avoid damaging the packing. Room temperature.