Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Laparoscopic trocar blade, reusable FDA UDI
- Device Name
- Trocar spike, 4 mm, blunt FDA UDI
- Model / Reference
- A70955A FDA UDI
- Description
- Trocar spike, 4 mm, blunt FDA UDI
Identifiers
- Catalog Number
- A70955A FDA UDI
- Primary DI / UDI-DI
- 04042761010597 FDA UDI
- 510(k) Number
- K951354 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Laparoscopic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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: Laparoscopic trocar blade, reusable
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic trocar blade, reusable.
- Snowden-Pencer — STERIS CORPORATION · Class II
- LOWFRIX — Karl Storz GmbH & Co. KG · Class II
- Integra® MicroFrance® — Integra Microfrance · Class II
- Sklar® — Sklar Corporation · Class II
- Gimmi — Gimmi GmbH · Class II
- Integra® MicroFrance® — Integra Microfrance · Class II
- Integra® MicroFrance® — Integra Microfrance · Class II
- Snowden-Pencer — STERIS CORPORATION · Class II
Cleared under the same submission
K951354 also covers:
- 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
- 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 c1c38ca1-f4eb-4bdd-bfc0-e922258acb8e 36 fields · synced May 31, 2026