Gel Care, 5.5"x 8"

GUDID 00614464007613

Silipos Holding LLC

Scar management dressing, single-use, non-sterile

• Primary Device ID: 00614464007613
• NIH Device Record Key: d8a2fa3f-1e5d-43d0-a9ef-dac6e85fb542
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gel Care, 5.5"x 8"
• Version Model Number: 761
• 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	00614464007613 [Primary]

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2022-08-15
• Device Publish Date: 2022-08-05

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• 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