Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Model / Reference
- A37009A FDA UDI
Identifiers
- Catalog Number
- A37009A FDA UDI
- Primary DI / UDI-DI
- 04042761023146 FDA UDI
- 510(k) Number
- K904939 FDA UDI
- FDA Product Code
- EZO FDA UDI
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual scalpel blade, single-use
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, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
Cleared under the same submission
K904939 also covers:
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 de3b6631-338f-4191-b9be-94fd2a51d5ed 35 fields · synced Jun 1, 2026