Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- The protection sleeve is used to protect the soft tissues while drilling the bone for the 4.0mm compression screws. This protection sleeve shall be inserted within the drilling guide with reference 119506ND. FDA UDI
- Model / Reference
- 119501ND FDA UDI
- Description
- The protection sleeve is used to protect the soft tissues while drilling the bone for the 4.0mm compression screws. This protection sleeve shall be inserted within the drilling guide with reference 119506ND. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780042938 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 6aed2ef2-9d31-44cf-b5cf-95d1f7a621c9 36 fields · synced Jun 8, 2026