Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is used to drill the bone for the insertion of the 6.5mm compression screw heads. It must be used through the external protecting sleeve with reference 119552ND. FDA UDI
- Model / Reference
- 119546ND FDA UDI
- Description
- The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is used to drill the bone for the insertion of the 6.5mm compression screw heads. It must be used through the external protecting sleeve with reference 119552ND. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780045311 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Cannulated surgical drill bit, single-use 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
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
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 3dd2c58c-7a0a-4dd7-95e8-f19c11e2895c 36 fields · synced Jun 8, 2026