Identity
- Trade Name
- EBA2 FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Model / Reference
- Disposable scalpel ø8x10mm FDA UDI
Identifiers
- Catalog Number
- 40470810 FDA UDI
- Primary DI / UDI-DI
- 08032909627646 FDA UDI
- 510(k) Number
- K131005 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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: Scalpel, single-use
Eba2 by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
- MANI ENT Knife — MANI, INC. · Class I
- Unique Edge — Unique Technologies, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
Cleared under the same submission
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
- Citieffe
Sources (1)
- FDA UDI 71cb7af4-3384-43b1-b4fc-5cb2af4f0e17 36 fields · synced May 30, 2026