Identity
- Trade Name
- X-CUBE FDA UDI
- Generic Name
- 5-Nucleotidase IVD, calibrator FDA UDI
- Device Name
- Foot Controller FDA UDI
- Model / Reference
- X-CUBE FDA UDI
- Description
- Foot Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260470293 FDA UDI
- 510(k) Number
- K092758 FDA UDI
- FDA Product Code
- EBW FDA UDI
- GMDN Term
- 5-Nucleotidase IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- 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
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: 5-Nucleotidase IVD, calibrator
X-Cube by Saeshin Precision Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 5-Nucleotidase IVD, calibrator.
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
- Saeshin Precision Co., Ltd.
Sources (1)
- FDA UDI f78ab344-7fd0-4363-ba8d-9617d10f6d0b 34 fields · synced May 30, 2026