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Viper Prime
EUDAMEDFDA UDIClass I (EU MDR)
Ref 286750041Model MEASURING INSTRUMENTS – SURGICAL DEPTH GAUGE
Identity
- Trade Name
- VIPER PRIME EUDAMEDFDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- REUSABLE DEPTH GAUGES EUDAMEDVIPER PRIME STYLET DEPTH ADJUSTOR FDA UDI
- Model / Reference
- MEASURING INSTRUMENTS – SURGICAL DEPTH GAUGE EUDAMED286750041 EUDAMEDFDA UDI
- Description
- VIPER PRIME STYLET DEPTH ADJUSTOR FDA UDI
Identifiers
- Catalog Number
- 286750041 FDA UDI
- Primary DI / UDI-DI
- 10705034507644 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0018367 EUDAMED
- Direct Marketing DI
- 10705034507644 EUDAMED
- 510(k) Number
- K170937 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
Yes
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
No
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: Surgical implant template, reusable
Viper Prime by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0705034a0018367 | 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 4b82dfde-a49d-4f73-8a28-9293c428f206 61 fields · synced Jul 16, 2026
- FDA UDI 5cae2c9d-df8e-48e2-9928-066dcd314354 36 fields · synced May 30, 2026