Identity
- Trade Name
- Trackable Suction - Suction Handle FDA UDI
- Generic Name
- Suction cannula, reusable FDA UDI
- Model / Reference
- SYN-0647 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00670082000177 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Suction cannula, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suction cannula, reusable
Trackable Suction - Suction Handle by Synaptive Medical Inc — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synaptive Medical Inc
Sources (2)
- FDA UDI c7fe0996-60e2-48c3-8249-d21f6b80d4af 32 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 28, 2026