Oleeva Fabric Umbilicoplasty Shape 37UM

GUDID 10810050460603

Silicone Gel Sheeting bonded with Fabric

Bio Med Sciences, Inc.

Scar management dressing, reusable
Primary Device ID10810050460603
NIH Device Record Key997f5933-26fd-4be7-b5b3-c33418da2e36
Commercial Distribution StatusIn Commercial Distribution
Brand NameOleeva Fabric Umbilicoplasty Shape
Version Model Number37UM
Catalog Number37UM
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 Dimensions

Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch
Width7 Centimeter
Width2.75 Inch
Length10 Centimeter
Length3.75 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050460606 [Primary]
GS110810050460603 [Package]
Contains: 00810050460606
Package: Box [10 Units]
In Commercial Distribution

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

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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

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