Identity
- Trade Name
- Emprint SX FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, clot activator/separator FDA UDI
- Device Name
- Open Ultrasound Tracking Sensor. For use with BK Medical. Type 8816 open ultrasound probes FDA UDI
- Model / Reference
- CABK8816 FDA UDI
- Description
- Open Ultrasound Tracking Sensor. For use with BK Medical. Type 8816 open ultrasound probes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521703339 FDA UDI
- FDA Product Code
- NEY FDA UDIGEI FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, clot activator/separator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Non-evacuated blood collection tube IVD, clot activator/separator
Emprint SX by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-evacuated blood collection tube IVD, clot activator/separator.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI b9779e7e-5662-4524-aa93-17cf2e3c9de8 35 fields · synced May 30, 2026