Identity
- Trade Name
- GP Remover Spear 0.3S EUDAMEDNA FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- GP Remover EUDAMEDThe device is an instrument used when treating patients with reinfected root canal to remove gutta percha, etc. attached to the root canal walls. FDA UDI
- Model / Reference
- GP Remover EUDAMED27131 EUDAMEDFDA UDI
- Description
- The device is an instrument used when treating patients with reinfected root canal to remove gutta percha, etc. attached to the root canal walls. FDA UDI
Identifiers
- Catalog Number
- 27131 FDA UDI
- Primary DI / UDI-DI
- 04963931271313 EUDAMEDFDA UDI
- Basic UDI-DI
- 4963931YDM00006WQ EUDAMED
- FDA Product Code
- EMN FDA UDI
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
GP Remover Spear 0.3S by Ydm Corporation — 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 | 4963931YDM00006WQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ydm Corporation
- EUDAMED SRN
- JP-MF-000011653
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 7c42d6a7-d2c5-44c9-9e68-5e07f9afd58b 61 fields · synced Jul 23, 2026
- FDA UDI f66dca48-f6ad-4f20-b012-88dc6474e4e2 35 fields · synced May 30, 2026