FDA UDI
In Commercial Distribution
🇺🇸 United States
ESTREMO
DI: 08051739536348
·
Model: Trocar for drill bit ø4mm
·
CITIEFFE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ESTREMO
- Primary DI
- 08051739536348
- Version / Model
- Trocar for drill bit ø4mm
- Catalog Number
- DT030027
- Company Name
- CITIEFFE SRL
- Labeler DUNS
- 431406875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-21
- Public Version
- 1
- Public Version Date
- 2020-03-02
- Public Version Status
- New
- Public Device Record Key
- 81d9b6f7-55a4-4eb4-a5ef-b0dd4dea1f4a
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 47457 | Orthopaedic trocar blade, reusable | A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08051739536348 | GS1 |
Customer Contacts
- Phone
- +39051721850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181540 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry and clean environment and avoid damaging the packing. Room temperature.