Optiform Feel OFE1AHH

GUDID 07613378135866

OPTIFORM FEEL AH-H 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: 07613378135866
• NIH Device Record Key: e0533041-f815-41bf-ae00-23c7ca6691dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiform Feel
• Version Model Number: OFE1AHH
• Catalog Number: OFE1AHH
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613378135866 [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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Optiform Feel]

• 07613378187766: OPTIFORM FEEL AE with closed finger CCL1. A custom sewn device from a flat knit compression temp
• 07613378187759: OPTIFORM FEEL AE with closed finger CCL2. A custom sewn device from a flat knit compression temp
• 07613378187742: OPTIFORM FEEL AE with closed finger CCL3. A custom sewn device from a flat knit compression temp
• 07613378187735: OPTIFORM FEEL AE with open finger CCL1. A custom sewn device from a flat knit compression templa
• 07613378187728: OPTIFORM FEEL AE with open finger CCL2. A custom sewn device from a flat knit compression templa
• 07613378187711: OPTIFORM FEEL AE with open finger CCL3. A custom sewn device from a flat knit compression templa
• 07613378187704: OPTIFORM FEEL AG with closed finger CCL1. A custom sewn device from a flat knit compression temp
• 07613378187698: OPTIFORM FEEL AG with closed finger CCL2. A custom sewn device from a flat knit compression temp
• 07613378187681: OPTIFORM FEEL AG with closed finger CCL3. A custom sewn device from a flat knit compression temp
• 07613378187674: OPTIFORM FEEL AG with open finger CCL1. A custom sewn device from a flat knit compression templa
• 07613378187667: OPTIFORM FEEL AG with open finger CCL2. A custom sewn device from a flat knit compression templa
• 07613378187650: OPTIFORM FEEL AG with open finger CCL3. A custom sewn device from a flat knit compression templa
• 07613378187643: OPTIFORM FEEL AH with closed finger CCL1. A custom sewn device from a flat knit compression temp
• 07613378187636: OPTIFORM FEEL AH with closed finger CCL2. A custom sewn device from a flat knit compression temp
• 07613378187629: OPTIFORM FEEL AH with closed finger CCL3. A custom sewn device from a flat knit compression temp
• 07613378187612: OPTIFORM FEEL AH with open finger CCL1. A custom sewn device from a flat knit compression templa
• 07613378187605: OPTIFORM FEEL AH with open finger CCL2. A custom sewn device from a flat knit compression templa
• 07613378187599: OPTIFORM FEEL AH with open finger CCL3. A custom sewn device from a flat knit compression templa
• 07613378187582: OPTIFORM FEEL AH-H with closed finger CCL1. A custom sewn device from a flat knit compression te
• 07613378187575: OPTIFORM FEEL AH-H with closed finger CCL2. A custom sewn device from a flat knit compression te
• 07613378187568: OPTIFORM FEEL AH-H with closed finger CCL3. A custom sewn device from a flat knit compression te
• 07613378187551: OPTIFORM FEEL AH-H with open finger CCL1. A custom sewn device from a flat knit compression temp
• 07613378187544: OPTIFORM FEEL AH-H with open finger CCL2. A custom sewn device from a flat knit compression temp
• 07613378187537: OPTIFORM FEEL AH-H with open finger CCL3. A custom sewn device from a flat knit compression temp
• 07613378135903: OPTIFORM FEEL AC1 CCL1. A custom sewn device from a flat knit compression template in the form o
• 07613378135897: OPTIFORM FEEL AE CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135880: OPTIFORM FEEL AG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135873: OPTIFORM FEEL AH CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135866: OPTIFORM FEEL AH-H CCL1. A custom sewn device from a flat knit compression template in the form
• 07613378135859: OPTIFORM FEEL CE CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135842: OPTIFORM FEEL CG CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135835: OPTIFORM FEEL CH CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135828: OPTIFORM FEEL CH-H CCL1. A custom sewn device from a flat knit compression template in the form
• 07613378135811: OPTIFORM FEEL ZX CCL1. A custom sewn device from a flat knit compression template in the form of
• 07613378135804: OPTIFORM FEEL AC1 CCL2. A custom sewn device from a flat knit compression template in the form o
• 07613378135798: OPTIFORM FEEL AE CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378135781: OPTIFORM FEEL AG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378135774: OPTIFORM FEEL AH CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378135767: OPTIFORM FEEL AH-H CCL2. A custom sewn device from a flat knit compression template in the form
• 07613378135750: OPTIFORM FEEL CE CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378135743: OPTIFORM FEEL CG CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378135736: OPTIFORM FEEL CH CCL2. A custom sewn device from a flat knit compression template in the form of
• 07613378135729: OPTIFORM FEEL CH-H CCL2. A custom sewn device from a flat knit compression template in the form
• 07613378135712: OPTIFORM FEEL AC1 CCL3. A custom sewn device from a flat knit compression template in the form o
• 07613378135705: OPTIFORM FEEL AE CCL3. A custom sewn device from a flat knit compression template in the form of
• 07613378135699: OPTIFORM FEEL AG CCL3. A custom sewn device from a flat knit compression template in the form of
• 07613378135682: OPTIFORM FEEL AH CCL3. A custom sewn device from a flat knit compression template in the form of
• 07613378135675: OPTIFORM FEEL AH-H CCL3. A custom sewn device from a flat knit compression template in the form
• 07613378135668: OPTIFORM FEEL CE CCL3. A custom sewn device from a flat knit compression template in the form of
• 07613378135651: OPTIFORM FEEL CG CCL3. A custom sewn device from a flat knit compression template in the form of