Silon-TSR Face Mask Design 2200P

GUDID 10810050460047

Perforated Temporary Skin Replacement

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 ID10810050460047
NIH Device Record Key95dee846-a061-48a5-8c1a-0b34f3aa5b8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilon-TSR Face Mask Design
Version Model Number2200P
Catalog Number2200P
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 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
GS100810050460040 [Primary]
GS110810050460047 [Package]
Contains: 00810050460040
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 Steriletrue

Device Entry Metadata

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

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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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