Identity
- Trade Name
- I.CO.S® FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire. FDA UDI
- Model / Reference
- 119510ND FDA UDI
- Description
- The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780044789 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 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 093625b9-2f04-4f1c-9465-944dcaf87aa6 35 fields · synced May 30, 2026