Oleeva Foam Breast Kit 32BKS

GUDID 10810050460245

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 ID10810050460245
NIH Device Record Key645a394d-f458-4b11-8c7c-ead728baa392
Commercial Distribution StatusIn Commercial Distribution
Brand NameOleeva Foam Breast Kit
Version Model Number32BKS
Catalog Number32BKS
Company DUNS364435974
Company NameBio Med Sciences, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com
Phone+1(610)530-3193
EmailBioMedCS@silon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050460248 [Primary]
GS110810050460245 [Package]
Contains: 00810050460248
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDAElastomer, silicone, for scar management

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-08
Device Publish Date2023-12-31

Devices Manufactured by Bio Med Sciences, Inc.

10810050460030 - Silon-TSR 11x122024-01-08 Perforated Temporary Skin Replacement
10810050460085 - Rylon-1 5x102024-01-08 Single-Sided Non-Adherent Wound Dressing
10810050460092 - Rylon-1 11x122024-01-08 Single-Sided Non-Adherent Wound Dressing
10810050460108 - Dual-Dress 50 11x122024-01-08 Foam Wound Dressing
10810050460115 - Dual-Dress 50 11x242024-01-08 Foam Wound Dressing
10810050460160 - Oleeva Foam 1.5x52024-01-08 Silicone Gel Sheeting bonded with Foam
10810050460177 - Oleeva Foam 5x52024-01-08 Silicone Gel Sheeting bonded with Foam
10810050460184 - Oleeva Foam 5x102024-01-08 Silicone Gel Sheeting bonded with Foam

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.