Scar Esthetique 60000

GUDID 00642790600000

Scar Esthetique Scar Creme with Silicone 60ml

Scar Heal

Scar-management dressing, single-use

• Primary Device ID: 00642790600000
• NIH Device Record Key: 7c3f504e-2d15-4593-b5d1-3d66c6d23746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scar Esthetique
• Version Model Number: 60000
• Catalog Number: 60000
• Company DUNS: 014302733
• Company Name: Scar Heal
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com
• Phone: 727-535-0022
• Email: hello@rejuvaskin.com

Device Dimensions

• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00642790600000 [Primary]

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

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: 2025-04-24
• Device Publish Date: 2025-04-16

Devices Manufactured by Scar Heal

• 00642790600000 - Scar Esthetique: 2025-04-24Scar Esthetique Scar Creme with Silicone 60ml
• 00642790600000 - Scar Esthetique: 2025-04-24 Scar Esthetique Scar Creme with Silicone 60ml
• 00642790101019 - Scar Fx: 2022-12-14 Scar Fx Silicone Sheeting 1"x1"
• 00642790100005 - Scar Fx: 2020-08-10 Scar Fx Silicone Sheeting 3" Breast Circle
• 00642790101125 - Scar Fx: 2020-08-10 Scar Fx Silicone Sheeting 1"x12"
• 00642790101224 - Scar Fx: 2020-08-10 Scar Fx Silicone Sheeting 1"x22"
• 00642790103051 - Scar Fx: 2020-08-10 Scar Fx Silicone Sheeting 3"x5"
• 00642790104089 - Scar Fx: 2020-08-10 Scar Fx Silicone Sheeting 4"x8"
• 00642790106489 - Scar Fx: 2020-08-10 Gelzone garment belt with silicone sheeting 6"x48"