Optiform Flex OF2AT

GUDID 07613378093494

Optiform Flex AT CCL2. 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: 07613378093494
• NIH Device Record Key: 18df57ff-4663-480d-a2d9-e459bb18102f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiform Flex
• Version Model Number: OF2AT
• Catalog Number: OF2AT
• 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
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613378093494 [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: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [Optiform Flex]

• 07613378105555: Optiform Flex AGT CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378105548: Optiform Flex AGT CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093777: Optiform Flex AB1 CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093760: Optiform Flex AD CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093753: Optiform Flex AG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093746: Optiform Flex AT CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093739: Optiform Flex AT1L CCL1. A custom sewn device from a flat knit compression template in the form
• 07613378093722: Optiform Flex B1D CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093715: Optiform Flex B1G CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093708: Optiform Flex B1T CCL1 men. A custom sewn device from a flat knit compression template in the fo
• 07613378093692: Optiform Flex B1T CCL1 women. A custom sewn device from a flat knit compression template in the
• 07613378093685: Optiform Flex BD CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093678: Optiform Flex BG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093661: Optiform Flex BT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093654: Optiform Flex BT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093647: Optiform Flex CG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093630: Optiform Flex CT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093623: Optiform Flex CT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093616: Optiform Flex DT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093609: Optiform Flex DT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093593: Optiform Flex EG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093586: Optiform Flex ET CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093579: Optiform Flex ET CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093562: Optiform Flex FT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093555: Optiform Flex FT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093548: Optiform Flex GT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093531: Optiform Flex GT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093524: Optiform Flex AB1 CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378093517: Optiform Flex AD CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093500: Optiform Flex AG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093494: Optiform Flex AT CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093487: Optiform Flex AT1L CCL2. A custom sewn device from a flat knit compression template in the form
• 07613378093470: Optiform Flex B1D CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378093463: Optiform Flex B1G CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378093456: Optiform Flex B1T CCL2 men. A custom sewn device from a flat knit compression template in the fo
• 07613378093449: Optiform Flex B1T CCL2 women. A custom sewn device from a flat knit compression template in the
• 07613378093432: Optiform Flex BD CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093425: Optiform Flex BG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093418: Optiform Flex BT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378093401: Optiform Flex BT CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378093395: Optiform Flex CG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093388: Optiform Flex CT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378093371: Optiform Flex CT CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378093364: Optiform Flex DT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378093357: Optiform Flex DT CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378093340: Optiform Flex EG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093333: Optiform Flex ET CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378093326: Optiform Flex ET CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378093319: Optiform Flex FT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378093302: Optiform Flex FT CCL2 women. A custom sewn device from a flat knit compression template in the f