"Active Ball Of Foot Gel Cushions, 1 Pair"

GUDID 00614464072154

Silipos Holding LLC

Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial Orthotic insole, prefabricated, antimicrobial

• Primary Device ID: 00614464072154
• NIH Device Record Key: eb9b8282-a927-440e-a8bb-f7802118fb08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "Active Ball Of Foot Gel Cushions, 1 Pair"
• Version Model Number: 7215
• Company DUNS: 056112948
• Company Name: Silipos Holding LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614464072154 [Primary]

FDA Product Code

• KYS: Insoles, Medical

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: 2022-09-01
• Device Publish Date: 2022-08-24

Devices Manufactured by Silipos Holding LLC

• 00614464350054 - Malleolar Gel Sleeve, Bulk: 2022-09-06
• 00614464011184 - Corn Pad, Wide, 6pcs/bag: 2022-09-01
• 00614464011351 - Extra Comfort Ball of Foot Cushions, 1 Pair/Pkg: 2022-09-01
• 00614464016257 - Cushion SiloLiner, 6" x 14": 2022-09-01
• 00614464040016 - Soft Zone Heel Spur w/Removable Plug, Small, 1pair/box: 2022-09-01
• 00614464040023 - Soft Zone Heel Spur w/Removable Plug, Medium, 1pair/box: 2022-09-01
• 00614464040030 - Soft Zone Heel Spur w/Removable Plug, Large, 1pair/box: 2022-09-01
• 00614464040054 - Softzone Low Profile Heel Cush, Medium, 1pair/box: 2022-09-01