Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of the 4.0mm compression screw will not be moved. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head. FDA UDI
- Model / Reference
- 119536ND FDA UDI
- Description
- The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw independently of its main body. The body (internal part) of the 4.0mm compression screw will not be moved. It has a specific spanner slotted-like tip with two threads opposite each other designed to fit the screw head. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780052128 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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 I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 08fc575e-a0f2-4309-a90d-ce6448e624d5 36 fields · synced May 31, 2026