Silon-TSR Face Mask Kit 2200P-K

GUDID 10810050460054

Perforated Temporary Skin Replacement Face Mask, Spandage® Tubular Net Dressing, Mastisol® Liquid Adhesion Promoter and5 pks. (2) Sterile 4” x 4” Absorbent Gauze Pads

Bio Med Sciences, Inc.

Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent Synthetic polymer semi-permeable film dressing, wound-nonadherent
Primary Device ID10810050460054
NIH Device Record Key526e9d13-a9e6-4c6e-8d13-22ae66c6fd1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilon-TSR Face Mask Kit
Version Model Number2200P-K
Catalog Number2200P-K
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 Kittrue
Device Combination Productfalse
Single Usetrue
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
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
GS100810050460057 [Primary]
GS110810050460054 [Package]
Contains: 00810050460057
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGPDressing, Wound And Burn, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-14
Device Publish Date2023-08-04

Devices Manufactured by Bio Med Sciences, Inc.

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10810050460092 - Rylon-1 11x122024-01-08 Single-Sided Non-Adherent Wound Dressing
10810050460108 - Dual-Dress 50 11x122024-01-08 Foam Wound Dressing
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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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