Identity
- Trade Name
- 5437 Bandages and Supplies FDA UDI
- Generic Name
- Non-woven gauze roll/sheet FDA UDI
- Device Name
- Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. FDA UDI
- Model / Reference
- 5437 FDA UDI
- Description
- Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. FDA UDI
Identifiers
- Catalog Number
- 5437 FDA UDI
- Primary DI / UDI-DI
- 00745129304560 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
Category: General-purpose medical foam padding, single-useWoven gauze roll/sheetNon-woven gauze roll/sheetCast stockinette
5437 Bandages and Supplies 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 754a1b11-5930-4fd3-880c-db8df9da9c9c 36 fields · synced May 30, 2026