Identity
- Trade Name
- PMT® Suction Instruments FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- MALLEABLE SURGICAL SUCTION, MICRO FDA UDI
- Model / Reference
- 9001-05-100 FDA UDI
- Description
- MALLEABLE SURGICAL SUCTION, MICRO FDA UDI
Identifiers
- Catalog Number
- 9001-05-100 FDA UDI
- Primary DI / UDI-DI
- 00650551045960 FDA UDI
- FDA Product Code
- GZX FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4525 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
No
FDA UDI
Hydrogen Peroxide FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDICatheter Gauge — 5 French FDA UDI
Category: Surgical irrigation/aspiration handpiece, reusable
PMT® Suction Instruments by Pmt Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration handpiece, reusable.
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Accu-Beam — Transamerican Technologies International · Class II
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- Plasdent — PLASDENT CORP. · Class I
- Walcott Rx Products — Walcott Rx Product Inc · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · 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
- Pmt Corp.
Sources (1)
- FDA UDI eb37d738-afa9-4841-85a9-7cde035206ff 37 fields · synced May 30, 2026