Optiform Hold OH2ETME

GUDID 07613378092848

Optiform Hold ET CCL2 men. 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: 07613378092848
• NIH Device Record Key: 47f877ac-f570-432c-ae6a-edd1d9d1e1fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiform Hold
• Version Model Number: OH2ETME
• Catalog Number: OH2ETME
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	07613378092848 [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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Optiform Hold]

• 07613378105562: Optiform Hold AGT CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093272: Optiform Hold AB1 CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093265: Optiform Hold AG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093258: Optiform Hold AT CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093241: Optiform Hold AT1L CCL1. A custom sewn device from a flat knit compression template in the form
• 07613378093234: Optiform Hold B1D CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093227: Optiform Hold B1G CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378093210: Optiform Hold B1T CCL1 men. A custom sewn device from a flat knit compression template in the fo
• 07613378093203: Optiform Hold B1T CCL1 women. A custom sewn device from a flat knit compression template in the
• 07613378093197: Optiform Hold BD CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093180: Optiform Hold BG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093173: Optiform Hold BT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093166: Optiform Hold BT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093159: Optiform Hold CG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093142: Optiform Hold CT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093135: Optiform Hold CT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093128: Optiform Hold DT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093111: Optiform Hold DT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093104: Optiform Hold EG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378093098: Optiform Hold ET CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093081: Optiform Hold ET CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093074: Optiform Hold FT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093067: Optiform Hold FT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093050: Optiform Hold GT CCL1 men. A custom sewn device from a flat knit compression template in the for
• 07613378093043: Optiform Hold GT CCL1 women. A custom sewn device from a flat knit compression template in the f
• 07613378093005: Optiform Hold AT CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378092923: Optiform Hold BT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378091582: Optiform Hold AD CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378105593: Optiform Hold AGT CCL4. A custom sewn device from a flat knit compression template in the form o
• 07613378105586: Optiform Hold AGT CCL3. A custom sewn device from a flat knit compression template in the form o
• 07613378105579: Optiform Hold AGT CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378093036: Optiform Hold AB1 CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378093029: Optiform Hold AD CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378093012: Optiform Hold AG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378092992: Optiform Hold AT1L CCL2. A custom sewn device from a flat knit compression template in the form
• 07613378092985: Optiform Hold B1D CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378092978: Optiform Hold B1G CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378092961: Optiform Hold B1T CCL2 men. A custom sewn device from a flat knit compression template in the fo
• 07613378092954: Optiform Hold B1T CCL2 women. A custom sewn device from a flat knit compression template in the
• 07613378092947: Optiform Hold BD CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378092930: Optiform Hold BG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378092916: Optiform Hold BT CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378092909: Optiform Hold CG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378092893: Optiform Hold CT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378092886: Optiform Hold CT CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378092879: Optiform Hold DT CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378092862: Optiform Hold DT CCL2 women. A custom sewn device from a flat knit compression template in the f
• 07613378092855: Optiform Hold EG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378092848: Optiform Hold ET CCL2 men. A custom sewn device from a flat knit compression template in the for
• 07613378092831: Optiform Hold ET CCL2 women. A custom sewn device from a flat knit compression template in the f