Identity
- Trade Name
- I.CO.S FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. It is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile and it is made from titanium alloy. FDA UDI
- Model / Reference
- 105440ND FDA UDI
- Description
- The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be driven forward and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. It is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile and it is made from titanium alloy. FDA UDI
Identifiers
- Catalog Number
- 105440ND FDA UDI
- Primary DI / UDI-DI
- 10381780046103 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
I.co.s by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 5de28711-9629-4915-89b9-011ce0b0a2cf 38 fields · synced Jun 1, 2026