Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- The cannulated internal tap is designed to prepare the thread of the 4mm compression screw heads. It is introduced through the protecting sleeve and screwed into the countersink area intended for the screw head and then gently unscrewed. FDA UDI
- Model / Reference
- 119525ND FDA UDI
- Description
- The cannulated internal tap is designed to prepare the thread of the 4mm compression screw heads. It is introduced through the protecting sleeve and screwed into the countersink area intended for the screw head and then gently unscrewed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780051831 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Bone tap, 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 0374c537-d751-4135-aaca-b0e779bfbdaf 36 fields · synced Jun 1, 2026