Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- SUCTION, OPEN TIP W/FINGER CONTROL 11" FDA UDI
- Model / Reference
- PMI4207021 FDA UDI
- Description
- SUCTION, OPEN TIP W/FINGER CONTROL 11" FDA UDI
Identifiers
- Catalog Number
- PMI4207021 FDA UDI
- Primary DI / UDI-DI
- 00850011214350 FDA UDI
- FDA Product Code
- CCW FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5540 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical irrigation/aspiration handpiece, reusable
Elmed by Progressive Medical Instrumentation Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 |
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Manufacturer
- Manufacturer
- Progressive Medical Instrumentation Inc
Sources (1)
- FDA UDI 10fe4a2a-12c4-41f3-8e14-57a9d24b8eaa 35 fields · synced May 31, 2026