Comforgel 736469

GUDID 08434048106554

Rest heel pads, gel

PRIM S.A.

Foot friction/impact protector

• Primary Device ID: 08434048106554
• NIH Device Record Key: 4a0f24cf-d2b0-4b2c-bd0f-e233ee0f6ede
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comforgel
• Version Model Number: CG0501
• Catalog Number: 736469
• 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	08434048106554 [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

On-Brand Devices [Comforgel]

• 08434048106554: Rest heel pads, gel
• 08434048106349: Extra-thin non-slip mini-insoles, Gel