Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The base is part of the container with reference 119976ND used in the transport and the sterillization of the I.CO.S® 6.5mm compression screw associated instruments and non-sterile implants. It is composed of one base and six silicone bumpers to securely maintain the devices. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
- Model / Reference
- 119958ND FDA UDI
- Description
- The base is part of the container with reference 119976ND used in the transport and the sterillization of the I.CO.S® 6.5mm compression screw associated instruments and non-sterile implants. It is composed of one base and six silicone bumpers to securely maintain the devices. The transport and sterilization containers are not intended to maintain sterility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780041924 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Device sterilization/disinfection container, 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 29eaf41d-8245-45d9-8a60-9cf6a251b16b 35 fields · synced May 30, 2026