Identity
- Trade Name
- Suction Irrigation System FDA UDI
- Generic Name
- Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Probe and Valve with dual bag tubing. FDA UDI
- Model / Reference
- C6001 FDA UDI
- Description
- Probe and Valve with dual bag tubing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00607915146498 FDA UDI
- FDA Product Code
- FHF FDA UDI
- GMDN Term
- Surgical irrigation/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4370 FDA UDI
- Commercial Distribution
- 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
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
No
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
- Length — 33 Centimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Surgical irrigation/aspiration cannula, non-illuminating, single-use
Suction Irrigation System by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration cannula, non-illuminating, single-use.
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Taiwan Surgical — Taiwan Surgical Corporation · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Single Use Professional — EAKIN SURGICAL LIMITED · Class II
- Elefant — Coloplast A/S · Class II
- OSSEOUS Suction Tube - Fine Tip — EON MEDITECH PRIVATE LIMITED · Class I
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
- Applied Medical Resources Corp.
Sources (1)
- FDA UDI 9fbed520-850b-43c8-b225-8f887d9738a4 35 fields · synced May 30, 2026