OPTIFORM TOE CAPS CCL1 357290

GUDID 07613378297069

OPTIFORM TOE CAPS CCL1. A custom sewn device from a flat knit compression template in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.

SIGVARIS INC

Compression/pressure tubular garment

• Primary Device ID: 07613378297069
• NIH Device Record Key: cf8c995c-1baa-44b0-9304-ed54411e9b0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIFORM TOE CAPS CCL1
• Version Model Number: 357290
• Catalog Number: 357290
• 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: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	07613378297069 [Primary]

FDA Product Code

• FQL: Stocking, Medical Support (For General Medical Purposes)

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: 2024-12-30
• Device Publish Date: 2024-12-20

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).