Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- Jaws "HiQ+", 5 x 330 mm, knot pusher Roeder FDA UDI
- Model / Reference
- WA64780A FDA UDI
- Description
- Jaws "HiQ+", 5 x 330 mm, knot pusher Roeder FDA UDI
Identifiers
- Catalog Number
- WA64780A FDA UDI
- Primary DI / UDI-DI
- 04042761067676 FDA UDI
- FDA Product Code
- GCJ FDA UDIHET FDA UDI
- GMDN Term
- Suture knot pusher, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 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
MR Conditional 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
K944200 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
K944201 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 3338fc2c-9271-4606-8c68-646a1829719b 36 fields · synced May 30, 2026