Identity
- Trade Name
- Rumex FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- Simcoe I/A Tip , Stainless Steel FDA UDI
- Model / Reference
- 7-080/SIM FDA UDI
- Description
- Simcoe I/A Tip , Stainless Steel FDA UDI
Identifiers
- Catalog Number
- 7-080/SIM FDA UDI
- Primary DI / UDI-DI
- 00840159900116 FDA UDI
- FDA Product Code
- KYG FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4360 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation/aspiration handpiece, reusable
Rumex by Rumex International Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration handpiece, reusable.
- Spetzler MacroVac® — Pmt Corp. · Class I
- SPETZLER MACROVAC® — Pmt Corp. · Class I
- Spetzler MacroVac® — Pmt Corp. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Accu-Beam — Transamerican Technologies International · Class II
- PMT® Suction Instruments — Pmt Corp. · Class I
- Spetzler MacroVac® — Pmt Corp. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rumex International Co.
Sources (1)
- FDA UDI 12864e49-6f8f-401a-9676-c85154b00c16 34 fields · synced Jun 9, 2026