Pinnacle Complete Curing Light Sleeve
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Pinnacle Curing Light Sleeve EUDAMEDPinnacle Complete Curing Light Sleeve FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- Barriers EUDAMEDCovers the Entire Curing Light from Handle to Tip FDA UDICuring Light Sleeve fits Demi FDA UDI
- Model / Reference
- DEMI250 EUDAMEDCLS250C FDA UDIDEMI250C FDA UDI
- Description
- Covers the Entire Curing Light from Handle to Tip FDA UDICuring Light Sleeve fits Demi FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00615375004739 EUDAMEDFDA UDI00615375004722 FDA UDI
- Basic UDI-DI
- 0615375000002QJ EUDAMED
- FDA Product Code
- MMP FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Instrument/equipment drape, single-use, non-sterile
Pinnacle Complete Curing Light Sleeve by Metrex Research — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Metrex Research
Sources (3)
- FDA UDI e330107a-df25-4d04-8060-b10f5fc2e32f 34 fields · synced Jul 14, 2026
- FDA UDI 62444be2-9098-4c1b-b323-f2856861ff96 34 fields · synced May 30, 2026
- EUDAMED 1f3f8903-ca95-442a-904c-c042599b288c 61 fields · synced Jul 14, 2026