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Viper System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 286730050Model Viper Reusable Osteosynthesis Instruments
Identity
- Trade Name
- VIPER SYSTEM EUDAMEDVIPER FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Viper Pedicle, Treaded Post, Derotation Frame, Tip Feeler, Fascia Separator, Rod Gauge EUDAMEDVIPER SYSTEM ROD GAUGE FDA UDI
- Model / Reference
- Viper Reusable Osteosynthesis Instruments EUDAMED286730050 EUDAMEDFDA UDI
- Description
- VIPER SYSTEM ROD GAUGE FDA UDI
Identifiers
- Catalog Number
- 286730050 FDA UDI
- Primary DI / UDI-DI
- 10705034214412 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001375Y EUDAMED
- Direct Marketing DI
- 10705034214412 EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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: Surgical implant template, reusable
Viper System 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 | 0705034a001375Y | 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 a44ee549-c547-4e08-a823-0051e381898f 61 fields · synced Jul 9, 2026
- FDA UDI 91351164-b13b-4a46-865b-f9f5462413bd 35 fields · synced May 30, 2026