Identity
- Trade Name
- 5055 Custom Bandaging Kit FDA UDI
- Generic Name
- Non-woven gauze roll/sheet FDA UDI
- Device Name
- Medical Vein - Custom Bandaging Kit with nonwoven padding and 3 rolls of inelastic compression bandages made without natural latex rubber FDA UDI
- Model / Reference
- 5055-MV FDA UDI
- Description
- Medical Vein - Custom Bandaging Kit with nonwoven padding and 3 rolls of inelastic compression bandages made without natural latex rubber FDA UDI
Identifiers
- Catalog Number
- 5055-MV FDA UDI
- Primary DI / UDI-DI
- 00745129328160 FDA UDI
- FDA Product Code
- FQM FDA UDIFMP FDA UDI
- GMDN Term
- Non-woven gauze roll/sheet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI880.6450 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 4 Inch FDA UDIWidth — 6.8 Centimeter FDA UDIWidth — 10 Centimeter FDA UDI
Category: Non-woven gauze roll/sheetPressure bandage, non-latex, reusable
5055 Custom Bandaging Kit by Sigvaris, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sigvaris, Inc.
Sources (1)
- FDA UDI cb19283c-2f58-4010-a923-242803326e10 36 fields · synced May 31, 2026