Identity
- Trade Name
- Bynex FDA UDI
- Generic Name
- Peristomal/periwound dressing FDA UDI
- Device Name
- Two-piece ostomy bag Flat Wafer FDA UDI
- Model / Reference
- NZ210551001-1 FDA UDI
- Description
- Two-piece ostomy bag Flat Wafer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06926515406387 FDA UDI
- FDA Product Code
- EXE FDA UDI
- GMDN Term
- Peristomal/periwound dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Peristomal/periwound dressing
Bynex by Zhende Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Eakin — T.G. EAKIN LIMITED · Class I
- Halyard — O&M HALYARD, INC. · Class I
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
- Zhende Medical Co., Ltd.
Sources (1)
- FDA UDI d8b5bef9-cad5-47e4-ad4b-ebdcb0994033 33 fields · synced May 30, 2026