Oleeva Foam 5.2x2.2 32BF

GUDID 10810050460221

Silicone Gel Sheeting bonded with Foam

Bio Med Sciences, Inc.

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

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10810050460115 - Dual-Dress 50 11x24	2024-01-08 Foam Wound Dressing
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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