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Perform™ Proximal Contact Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref CF100Ref CF200-S
Identity
- Trade Name
- Perform™ Proximal Contact Instruments EUDAMEDPerForm™ FDA UDI
- Generic Name
- Dental restoration carver, resin FDA UDI
- Device Name
- Instruments Family EUDAMEDProximal Contact Instrument, Large Tip FDA UDI
- Model / Reference
- CF100 EUDAMEDCF200-S EUDAMEDFDA UDI
- Description
- Proximal Contact Instrument, Large Tip FDA UDI
Identifiers
- Catalog Number
- CF200-S FDA UDI
- Primary DI / UDI-DI
- 10810038093809 EUDAMED00810038093819 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809InstrumentsTFTF EUDAMED
- FDA Product Code
- EIY FDA UDI
- EMDN Code
- L159013 DENTAL SPATULAS, REUSABLE EUDAMED
- GMDN Term
- Dental restoration carver, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Perform™ Proximal Contact Instruments by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809InstrumentsTFTF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (3)
- EUDAMED 2c79a69b-05a9-42cd-9681-23396d72ff5e 61 fields · synced Jul 17, 2026
- EUDAMED f7f25a8d-f4b9-4319-bf1b-45bc8f775b3c 61 fields · synced May 18, 2026
- FDA UDI 64d1fe51-c61b-4dfc-b9b0-7ec2d48d12ac 35 fields · synced May 30, 2026