Suction Sterilizable Storage Tray
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- SUCTION STERILIZABLE STORAGE TRAY EUDAMEDTrackable Suction - Sterilizable Storage Tray FDA UDI
- Generic Name
- Suction cannula, reusable FDA UDI
- Device Name
- Trackable Suction - Suction Set Standard EUDAMED
- Model / Reference
- SYN-0657 EUDAMEDSYN-0618 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00670082000146 EUDAMEDFDA UDI
- Basic UDI-DI
- 67008200003LM EUDAMED
- Direct Marketing DI
- 00670082000146 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical/emergency suction cannula, non-illuminating, reusable
Suction Sterilizable Storage Tray by Synaptive Medical Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- MicroFrance® — Integra Microfrance · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCANLAN® Variable Suction Rotatable Tips — SCANLAN INTERNATIONAL INC · Class I
- Fukushima Tear Drop Suction Tube Straight Malleable 10 Fr. 21 cm - 8 1/4" Ø 3.3 mm — SURTEX INSTRUMENTS LTD · Class IIa
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synaptive Medical Inc.
- EUDAMED SRN
- CA-MF-000010705
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e9260c98-d197-41ff-b33a-a1c36f4cc97c 61 fields · synced Jun 20, 2026
- FDA UDI a9e0ddd9-a2c9-4f1d-b1f5-23f6b2e8762b 32 fields · synced May 29, 2026