Identity
- Trade Name
- Pinnacle Demi ultra Curing Light Sleeve EUDAMEDPinnacle Cure Sleeve FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- Barriers EUDAMEDCustomFitted for the Kerr Demi Ultra LED Curing Light with UltraSoft Material FDA UDI
- Model / Reference
- DEMIULTRA-100 EUDAMEDDEMIULTRA-100C FDA UDI
- Description
- CustomFitted for the Kerr Demi Ultra LED Curing Light with UltraSoft Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00615375004746 EUDAMEDFDA 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Instrument/equipment drape, single-use, non-sterile
Pinnacle Cure 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
European Union Unknown
MDR
United States Pending data
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 (2)
- FDA UDI 503dea7c-02e1-4ed4-8a19-1664684a36a1 34 fields · synced Jul 13, 2026
- EUDAMED 4edda6e1-0bad-46f8-b041-dd798bf9bdcd 61 fields · synced Jul 13, 2026