Identity
- Trade Name
- 579 Melany Donning & Doffing Small FDA UDI
- Generic Name
- Assistive sock/pantyhose dressing device FDA UDI
- Device Name
- A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). FDA UDI
- Model / Reference
- 309387 FDA UDI
- Description
- A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). FDA UDI
Identifiers
- Catalog Number
- 579MSM FDA UDI
- Primary DI / UDI-DI
- 07613378105340 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Assistive sock/pantyhose dressing device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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: Assistive sock/pantyhose dressing device
579 Melany Donning & Doffing Small 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 2c32e2ec-b221-4991-ba5e-8ed80bbf4bfe 36 fields · synced May 30, 2026