Identity
- Trade Name
- Pinnacle Cure Sleeve FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, non-sterile FDA UDI
- Device Name
- Curing Light Tip Sleeves Fits 7 and 8mm Tips FDA UDI
- Model / Reference
- 4500C FDA UDI
- Description
- Curing Light Tip Sleeves Fits 7 and 8mm Tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00615375004630 FDA UDI
- FDA Product Code
- MMP 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
No
FDA UDI
Category: Cable/lead/sensor/probe cover, non-sterile
Pinnacle Cure Sleeve by Metrex Research — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cable/lead/sensor/probe cover, non-sterile.
- Light Shield — MASIMO CORPORATION · Class II
- Masimo Ambient Shield Accessory — MASIMO CORPORATION · Class II
- RINN® — Dentsply International · Class II
- Sani-Tip® — Dentsply Professional · Class I
- Disposa-Shield® — Dentsply Professional · Class I
- Sani-Tip® — Dentsply Professional · Class I
- Disposa-Shield® — Dentsply Professional · Class II
- Disposa-Shield® — Dentsply Professional · Class I
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
- Metrex Research
Sources (1)
- FDA UDI 9157332f-ba98-4acf-9636-f5bf20dfbcf2 34 fields · synced May 31, 2026