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Syn Tube 10-L-30 Suction Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SYN-0652Model SYN-0657
Identity
- Trade Name
- SYN TUBE 10-L-30 SUCTION INSTRUMENT EUDAMEDTrackable Suction - Tube 10-L-30 FDA UDI
- Generic Name
- Suction cannula, reusable FDA UDI
- Device Name
- Trackable Suction - Suction Set Standard EUDAMED
- Model / Reference
- SYN-0657 EUDAMEDSYN-0652 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00670082000207 EUDAMEDFDA UDI
- Basic UDI-DI
- 67008200003LM EUDAMED
- Direct Marketing DI
- 00670082000207 EUDAMED
- FDA Product Code
- GCX FDA UDI
- EMDN Code
- L030101 SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Suction cannula, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Syn Tube 10-L-30 Suction Instrument by Synaptive Medical Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 67008200003LM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Synaptive Medical Inc.
- EUDAMED SRN
- CA-MF-000010705
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED c61a8bf8-e237-4360-87d5-c599aba13f68 61 fields · synced Jun 18, 2026
- FDA UDI 87d14006-0860-4386-93c4-a0114e5c97dd 32 fields · synced May 25, 2026