579 Melany Donning & Doffing MEDIUM 579MMD

GUDID 07613378105333

A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

SIGVARIS INC

Assistive sock/pantyhose dressing device

• Primary Device ID: 07613378105333
• NIH Device Record Key: dbe1fbf1-8e8e-497a-a77d-7c5255351fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 579 Melany Donning & Doffing MEDIUM
• Version Model Number: 309388
• Catalog Number: 579MMD
• Company DUNS: 189738719
• Company Name: SIGVARIS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613378105333 [Primary]

FDA Product Code

• IKX: Aid, Transfer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-04
• Device Publish Date: 2025-01-27

Devices Manufactured by SIGVARIS INC

• 00745129315962 - Cflex Contain Full Leg MD MD MD Reg Right Black: 2025-02-20 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129317522 - 143C MicroFiber Shades 15-20mmHg W A BlueButterfly: 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129317539 - 143C MicroFiber Shades 15-20mmHg W B BlueButterfly: 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129317546 - 143C MicroFiber Shades 15-20mmHg W C BlueButterfly: 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129317553 - 183C MicroFiber Shades 15-20mmHg M A BlueButterfly: 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129317560 - 183C MicroFiber Shades 15-20mmHg M B BlueButterfly: 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 00745129317577 - 183C MicroFiber Shades 15-20mmHg M C Blue Butterflies: 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u
• 07613378105326 - 579 Melany Donning & Doffing Large: 2025-02-04 A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).