Identity
- Trade Name
- Hayden Medical FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- 5mm Laparoscopic Knot Pusher (black handle), open end, 32cm working length FDA UDI
- Model / Reference
- HE13-1616O FDA UDI
- Description
- 5mm Laparoscopic Knot Pusher (black handle), open end, 32cm working length FDA UDI
Identifiers
- Catalog Number
- HE13-1616O FDA UDI
- Primary DI / UDI-DI
- 00840319734407 FDA UDI
- 510(k) Number
- K974382 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suture knot pusher, 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: Suture knot pusher, reusable
Hayden Medical by Hayden Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture knot pusher, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- PASHLEY LARYNGOSCOPE KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class I
- Closed Knot Pusher — Biomet Orthopedics, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- MICTEC KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
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
- Novo Surgical — NOVO SURGICAL, 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 9d49f0c2-d3f1-494d-875a-ab1fe0069f68 36 fields · synced Jun 8, 2026