Identity
- Trade Name
- Single Use Surgical Professional FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Device Name
- Sinus 12fg 90 Degrees Curve No Control Hole FDA UDI
- Model / Reference
- S164 FDA UDI
- Description
- Sinus 12fg 90 Degrees Curve No Control Hole FDA UDI
Identifiers
- Catalog Number
- S164 FDA UDI
- Primary DI / UDI-DI
- 05055299102572 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 90 degree FDA UDICatheter Gauge — 12 French FDA UDI
Single Use Surgical Professional by Eakin Surgical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eakin Surgical Limited
Sources (1)
- FDA UDI 562d0453-f8e0-4ca4-896d-b1a83f28cc31 37 fields · synced Jun 6, 2026