Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- The internal protecting sleeve is used to protect the soft tissues while drilling the bone for the 6.5mm compression screws. This protecting sleeve shall be inserted within the external protection sleeve referenced 119552ND. The drilling guide referenced 119541ND shall be inserted within this internal protecting sleeve. FDA UDI
- Model / Reference
- 119551ND FDA UDI
- Description
- The internal protecting sleeve is used to protect the soft tissues while drilling the bone for the 6.5mm compression screws. This protecting sleeve shall be inserted within the external protection sleeve referenced 119552ND. The drilling guide referenced 119541ND shall be inserted within this internal protecting sleeve. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042969 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 98e22138-f9e7-4ff5-9b8b-8f5b9ee6f165 36 fields · synced May 30, 2026