Identity
- Trade Name
- Zibone FDA UDI
- Generic Name
- Manual scalpel blade, reusable FDA UDI
- Device Name
- #11 BLADE (Used with the handle CST-H04) FDA UDI
- Model / Reference
- CST-B11 FDA UDI
- Description
- #11 BLADE (Used with the handle CST-H04) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710986431298 FDA UDI
- FDA Product Code
- GES FDA UDI
- GMDN Term
- Manual scalpel blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual scalpel blade, reusable
Zibone by Coho Biomedical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Olympus — Olympus Winter & Ibe GmbH · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Coho Biomedical Technology Co., Ltd.
Sources (1)
- FDA UDI 9e46279a-bba4-48bf-ac3d-1012246ec6d1 33 fields · synced May 30, 2026