Spotlight Access System
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- SPOTLIGHT ACCESS SYSTEM EUDAMEDSPOTLIGHT FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- Spotlight port , light source, line powered EUDAMEDSPOTLIGHT ACCESS SYSTEM ILLUMINATED ANATOMIC PORT 12 x 70mm FDA UDI
- Model / Reference
- Spotlight Port Instruments EUDAMED282912570 EUDAMEDFDA UDI
- Description
- SPOTLIGHT ACCESS SYSTEM ILLUMINATED ANATOMIC PORT 12 x 70mm FDA UDI
Identifiers
- Catalog Number
- 282912570 FDA UDI
- Primary DI / UDI-DI
- 10705034205786 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a002145R EUDAMED
- Direct Marketing DI
- 10705034205786 EUDAMED
- 510(k) Number
- K062814 FDA UDI
- FDA Product Code
- GZT FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
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: Endoscopic light source unit, line-powered
A comprehensive medical device directory listing the Spotlight Access System, including its companion diagnostics, UDI data ULID, and trade name. It provides key features, compliance information, FAQs, and more.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002145R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 74e8630e-7563-48b0-94ab-cb3e7b11a727 61 fields · synced Jun 28, 2026
- FDA UDI 0811c467-47ae-456b-812f-d055a948885b 36 fields · synced May 30, 2026