Identity
- Trade Name
- Sani-Shield® FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, non-sterile FDA UDI
- Device Name
- Sani-Shield® Disposable Barrier for Air/Water Syringes FDA UDI
- Model / Reference
- 130010 FDA UDI
- Description
- Sani-Shield® Disposable Barrier for Air/Water Syringes FDA UDI
Identifiers
- Primary DI / UDI-DI
- D0031300101 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Category: Cable/lead/sensor/probe cover, non-sterile
Sani-Shield® by Dentsply Professional — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RINN® — Dentsply International · Class II
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
- Dentsply Professional
Sources (1)
- FDA UDI b2e729e8-fa5d-47b3-8f0f-0d385e1a4052 34 fields · synced Jun 8, 2026