Oleeva Fabric Breast Kit 37BK

GUDID 10810050460528

Scar management dressing, reusable

Primary Device ID	10810050460528
NIH Device Record Key	e1114eb9-7dff-425a-a337-a700c588d010
Commercial Distribution Status	In Commercial Distribution
Brand Name	Oleeva Fabric Breast Kit
Version Model Number	37BK
Catalog Number	37BK
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

Device Issuing Agency	Device ID
GS1	00810050460521 [Primary]
GS1	10810050460528 [Package] Contains: 00810050460521 Package: Box [10 Units] In Commercial Distribution

MDA	Elastomer, silicone, for scar management

Steralize Prior To Use	false
Device Is Sterile	false

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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
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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