Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Endoscopic surgical probe FDA UDI
- Device Name
- Guiding rod, 4 mm FDA UDI
- Model / Reference
- A70958A FDA UDI
- Description
- Guiding rod, 4 mm FDA UDI
Identifiers
- Catalog Number
- A70958A FDA UDI
- Primary DI / UDI-DI
- 04042761010603 FDA UDI
- 510(k) Number
- K951354 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Endoscopic surgical probe 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: Endoscopic surgical probe
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic surgical probe.
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- MAGNETIC PROBE — SONTEC INSTRUMENTS, INC. · Class I
- Tecomet — Tecomet,Inc · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
- Rasp Probe — Biomet Orthopedics, Inc. · Class I
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 53048007-ddb6-4554-8af2-6d5ee553cc52 36 fields · synced May 31, 2026