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Spotlight Access System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 292903404Model Spotlight Instruments Bone Spoons and Curettes
Identity
- Trade Name
- SPOTLIGHT ACCESS SYSTEM EUDAMEDSPOTLIGHT FDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Spotlight Instruments Ronguer Curette Pituitary EUDAMEDSPOTLIGHT ACCESS SYSTEM DOWN BITING CURETTE 4mm FDA UDI
- Model / Reference
- Spotlight Instruments Bone Spoons and Curettes EUDAMED292903404 EUDAMEDFDA UDI
- Description
- SPOTLIGHT ACCESS SYSTEM DOWN BITING CURETTE 4mm FDA UDI
Identifiers
- Catalog Number
- 292903404 FDA UDI
- Primary DI / UDI-DI
- 10705034225654 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0008362 EUDAMED
- Direct Marketing DI
- 10705034225654 EUDAMED
- FDA Product Code
- HTF FDA UDI
- EMDN Code
- L0901 ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE EUDAMED
- GMDN Term
- Bone curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone curette, reusable
Spotlight Access System by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone curette, reusable.
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- Volkmann Bone Curette Oval - Fig. 00 17 cm - 6 3/4" Scoop Size 4.4 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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 | 0705034a0008362 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED cc74acc0-e273-47ce-b421-3981d8bc25af 61 fields · synced Jun 19, 2026
- FDA UDI c2d399e2-6fa3-471f-b5b4-1846ce41e1e6 35 fields · synced May 30, 2026