Identity
- Trade Name
- Hayden Medical FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- 5mm Suction / Irrigation Tube with stopcock, 33cm working length FDA UDI
- Model / Reference
- HE11-1270 FDA UDI
- Description
- 5mm Suction / Irrigation Tube with stopcock, 33cm working length FDA UDI
Identifiers
- Catalog Number
- HE11-1270 FDA UDI
- Primary DI / UDI-DI
- 00840319734353 FDA UDI
- 510(k) Number
- K974382 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical irrigation/aspiration handpiece, reusable
Hayden Medical by Hayden Medical Inc — Class II — 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
Cleared under the same submission
K974382 also covers:
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Novo Surgical — NOVO SURGICAL, INC.
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
- Hayden Medical Inc
Sources (1)
- FDA UDI 1b027cd0-ff77-47a9-8276-3115a9996857 36 fields · synced Jun 8, 2026