Identity
- Trade Name
- DYNA-FLEX™ FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- Multi-Layer Compression System FDA UDI
- Model / Reference
- 7025 FDA UDI
- Description
- Multi-Layer Compression System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15051978003427 FDA UDI
- FDA Product Code
- MCY FDA UDI
- GMDN Term
- Compression bandaging kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5075 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Compression bandaging kit
Dyna-Flex™ by Systagenix Wound Management, Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Systagenix Wound Management, Limited
Sources (1)
- FDA UDI 12a68470-31a7-497a-828e-eb18194eb034 34 fields · synced May 30, 2026