Comforsil

GUDID 08431082070216

Silicone insoles with anti-impact discharge

PRIM S.A.

Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial Orthotic insole, prefabricated, non-antimicrobial

• Primary Device ID: 08431082070216
• NIH Device Record Key: 4d41a1c5-0c4c-4c73-a2df-982f2d5f2268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comforsil
• Version Model Number: CC209XL
• Company DUNS: 462011560
• Company Name: PRIM S.A.
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08431082070216 [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: 2024-03-18
• Device Publish Date: 2024-03-08

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• 08431082070216: Silicone insoles with anti-impact discharge
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