Silon-LTS 12x18 4716

GUDID 10810050460658

Low Temperature Splinting

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 ID10810050460658
NIH Device Record Key5e22b75d-bef7-4a58-94d3-086d6d266e50
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilon-LTS 12x18
Version Model Number4716
Catalog Number4716
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-Counterfalse

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

Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter
Length18 Inch
Width12 Inch
Length46 Centimeter
Width30 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050460651 [Primary]
GS110810050460658 [Package]
Contains: 00810050460651
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

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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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