Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Manual scalpel blade, reusable FDA UDI
- Device Name
- Knife, semi-circular, for A3550 FDA UDI
- Model / Reference
- A3558 FDA UDI
- Description
- Knife, semi-circular, for A3550 FDA UDI
Identifiers
- Catalog Number
- A3558 FDA UDI
- Primary DI / UDI-DI
- 04042761005302 FDA UDI
- 510(k) Number
- K904940 FDA UDI
- FDA Product Code
- FJL FDA UDI
- GMDN Term
- Manual scalpel blade, 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: Manual scalpel 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 Manual scalpel blade, reusable.
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- SP — Cardinal Health 200, LLC · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
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- MICRO FEATHER MICROSURGICAL BLADE for fine incision — FEATHER SAFETY RAZOR CO., LTD. · Class I
Cleared under the same submission
K904940 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
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
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI ead9910b-b822-4856-b183-0974304a912c 36 fields · synced May 30, 2026