Oleeva Clear 8x12 3596

GUDID 10810050460313

Silicone Gel Sheeting

Bio Med Sciences, Inc.

Scar management dressing, reusable

• Primary Device ID: 10810050460313
• NIH Device Record Key: 9af8d503-833d-4b5a-bb72-ed0f38d7a5d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oleeva Clear 8x12
• Version Model Number: 3596
• Catalog Number: 3596
• 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

• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch
• Length: 30 Centimeter
• Width: 20 Centimeter
• Length: 12 Inch
• Width: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050460316 [Primary]
GS1	10810050460313 [Package]; Contains: 00810050460316; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982036

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.

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• 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