Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- Jaws "HiQ+", 5 x 330 mm, knot pusher FDA UDI
- Model / Reference
- WA64790A FDA UDI
- Description
- Jaws "HiQ+", 5 x 330 mm, knot pusher FDA UDI
Identifiers
- Catalog Number
- WA64790A FDA UDI
- Primary DI / UDI-DI
- 04042761030908 FDA UDI
- FDA Product Code
- EWY FDA UDIGCJ FDA UDI
- GMDN Term
- Suture knot pusher, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4720 FDA UDI876.1500 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
Olympus by Olympus Winter & Ibe GmbH — 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
- Hayden Medical — Hayden Medical Inc · Class II
- 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
Cleared under the same submission
K912362 also covers:
- Olmypus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
K923982 also covers:
- Olmypus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI e6cc5370-d544-4c21-9999-fad0faf7e3c9 36 fields · synced May 29, 2026