Oleeva Foam 5.2x2.2 32BF

GUDID 10810050460221

Silicone Gel Sheeting bonded with Foam

Bio Med Sciences, Inc.

Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable

• Primary Device ID: 10810050460221
• NIH Device Record Key: 2567a1e7-727f-4df2-9e70-c45726fe730e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oleeva Foam 5.2x2.2
• Version Model Number: 32BF
• Catalog Number: 32BF
• Company DUNS: 364435974
• Company Name: Bio Med Sciences, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com
• Phone: +1(610)530-3193
• Email: BioMedCS@silon.com

Device Dimensions

• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch
• Width: 5.2 Inch
• Width: 13.2 Centimeter
• Length: 5.6 Centimeter
• Length: 2.2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050460224 [Primary]
GS1	10810050460221 [Package]; Contains: 00810050460224; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002109

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: 2024-01-08
• Device Publish Date: 2023-12-31

Devices Manufactured by Bio Med Sciences, Inc.

• 10810050460030 - Silon-TSR 11x12: 2024-01-08 Perforated Temporary Skin Replacement
• 10810050460085 - Rylon-1 5x10: 2024-01-08 Single-Sided Non-Adherent Wound Dressing
• 10810050460092 - Rylon-1 11x12: 2024-01-08 Single-Sided Non-Adherent Wound Dressing
• 10810050460108 - Dual-Dress 50 11x12: 2024-01-08 Foam Wound Dressing
• 10810050460115 - Dual-Dress 50 11x24: 2024-01-08 Foam Wound Dressing
• 10810050460160 - Oleeva Foam 1.5x5: 2024-01-08 Silicone Gel Sheeting bonded with Foam
• 10810050460177 - Oleeva Foam 5x5: 2024-01-08 Silicone Gel Sheeting bonded with Foam
• 10810050460184 - Oleeva Foam 5x10: 2024-01-08 Silicone Gel Sheeting bonded with Foam