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Orascoptic - Endeavour XL Headlight System
FDA UDIEUDAMEDClass I (US FDA UDI)
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Identity
- Trade Name
- Orascoptic - Endeavour XL Headlight System FDA UDIOrascoptic - Spark TruColor Headlight System FDA UDIOrascoptic - Endeavour Headlight System FDA UDIOrascoptic - Endeavour TruColor Headlight System FDA UDIOrascoptic - Endeavour TruColor XL Headlight System FDA UDISpark TruColor FDA UDIEndeavour MD FDA UDI
- Generic Name
- General-purpose light source FDA UDISurgical binoculars, reusable FDA UDI
- Device Name
- Spark Headlight EUDAMEDNA FDA UDIFINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, EUROPE w/SOFT CASE FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, JAW FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, UNIVERSAL FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, TTL FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, JAW FDA UDI
- Model / Reference
- 910119-68 EUDAMEDFDA UDI910119-24 EUDAMEDFDA UDI910131-22 EUDAMEDFDA UDI910119-63 EUDAMEDFDA UDI910119-26 EUDAMEDFDA UDI910131-24 EUDAMEDFDA UDI910131-67 EUDAMEDFDA UDI910119-28 EUDAMEDFDA UDI910131-66 EUDAMEDFDA UDI910174-22 EUDAMEDFDA UDI910176-13 EUDAMEDFDA UDI910131-62 EUDAMEDFDA UDI910176-12 EUDAMEDFDA UDI910119-66 EUDAMEDFDA UDI910131-63 EUDAMEDFDA UDI910119-70 EUDAMEDFDA UDI910175-11 EUDAMEDFDA UDI910119-23 EUDAMEDFDA UDI910131-27 EUDAMEDFDA UDI910131-70 EUDAMEDFDA UDI910131-65 EUDAMEDFDA UDI910119-65 EUDAMEDFDA UDI910131-61 EUDAMEDFDA UDI910175-13 EUDAMEDFDA UDI910119-30 EUDAMEDFDA UDI910131-21 EUDAMEDFDA UDI910119-61 EUDAMEDFDA UDI910131-23 EUDAMEDFDA UDI910131-28 EUDAMEDFDA UDI910119-62 EUDAMEDFDA UDI910177-21 EUDAMED910177-61 EUDAMED910177-26 EUDAMED910184-12 EUDAMED910184-11 EUDAMED910177-70 EUDAMED910179-12 EUDAMED910178-11 EUDAMED910177-27 EUDAMED910179-13 EUDAMED910177-23 EUDAMED910177-62 EUDAMED910177-64 EUDAMED910177-68 EUDAMED910177-63 EUDAMED910177-22 EUDAMED910181-22 EUDAMED910133-12 FDA UDI
- Description
- NA FDA UDIFINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, EUROPE w/SOFT CASE FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, JAW FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, DOUBLE, INTERNATIONAL, UNIVERSAL FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, TTL FDA UDIFINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, JAW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00615375009512 EUDAMEDFDA UDI00615375009383 EUDAMEDFDA UDI00615375011300 EUDAMEDFDA UDI00615375009468 EUDAMEDFDA UDI00615375009406 EUDAMEDFDA UDI00615375011324 EUDAMEDFDA UDI00615375011539 EUDAMEDFDA UDI00615375009420 EUDAMEDFDA UDI00615375011522 EUDAMEDFDA UDI00615375013281 EUDAMEDFDA UDI00615375013441 EUDAMEDFDA UDI00615375011485 EUDAMEDFDA UDI00615375013434 EUDAMEDFDA UDI00615375009499 EUDAMEDFDA UDI00615375011492 EUDAMEDFDA UDI00615375009529 EUDAMEDFDA UDI00615375013366 EUDAMEDFDA UDI00615375009376 EUDAMEDFDA UDI00615375011355 EUDAMEDFDA UDI00615375011553 EUDAMEDFDA UDI00615375011515 EUDAMEDFDA UDI00615375009482 EUDAMEDFDA UDI00615375011461 EUDAMEDFDA UDI00615375013380 EUDAMEDFDA UDI00615375009437 EUDAMEDFDA UDI00615375011294 EUDAMEDFDA UDI00615375009444 EUDAMEDFDA UDI00615375011317 EUDAMEDFDA UDI00615375011362 EUDAMEDFDA UDI00615375009451 EUDAMEDFDA UDI00615375013625 EUDAMED00615375013809 EUDAMED00615375013670 EUDAMED00810210820318 EUDAMED00810210820301 EUDAMED00615375013885 EUDAMED00615375013991 EUDAMED00615375013922 EUDAMED00615375013687 EUDAMED00615375014004 EUDAMED00615375013649 EUDAMED00615375013816 EUDAMED00615375013830 EUDAMED00615375013878 EUDAMED00615375013823 EUDAMED00615375013632 EUDAMED00615375014165 EUDAMED00615375011591 FDA UDI
- Basic UDI-DI
- 06153753000001EM EUDAMED
- FDA Product Code
- EBA FDA UDIFSP FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- General-purpose light source FDA UDISurgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4630 FDA UDI878.4800 FDA UDI
- Market of Registration
- Italy 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose light source
Orascoptic - Endeavour XL Headlight System by Metrex Research — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Metrex Research
Sources (78)
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