Softzone Insole, 3/4 Length, Large, 1pair/box

GUDID 00614464040122

Silipos Holding LLC

Orthotic insole, prefabricated, antimicrobial

• Primary Device ID: 00614464040122
• NIH Device Record Key: eca8d5d7-17a7-4033-a37d-db9ae7bab2d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Softzone Insole, 3/4 Length, Large, 1pair/box
• Version Model Number: 4012
• 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	00614464040122 [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