Silon-LTS 12x18 4716

GUDID 10810050460658

Low Temperature Splinting

Bio Med Sciences, Inc.

Scar management dressing, reusable

Primary Device ID	10810050460658
NIH Device Record Key	5e22b75d-bef7-4a58-94d3-086d6d266e50
Commercial Distribution Status	In Commercial Distribution
Brand Name	Silon-LTS 12x18
Version Model Number	4716
Catalog Number	4716
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	false

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

Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter
Length	18 Inch
Width	12 Inch
Length	46 Centimeter
Width	30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050460651 [Primary]
GS1	10810050460658 [Package] Contains: 00810050460651 Package: Box [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K945892

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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