Oleeva Foam Breast Areola Shape 32BA

GUDID 10810050460214

Silicone Gel Sheeting bonded with Foam

Bio Med Sciences, Inc.

Scar management dressing, reusable

• Primary Device ID: 10810050460214
• NIH Device Record Key: c0981bf4-c968-4069-8633-ebfebcbcdc12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oleeva Foam Breast Areola Shape
• Version Model Number: 32BA
• Catalog Number: 32BA
• 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

• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter
• Outer Diameter: 2.5 Inch
• Outer Diameter: 6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050460217 [Primary]
GS1	10810050460214 [Package]; Contains: 00810050460217; 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

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• 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