Mederma Medical Grade Silicone Scar Sheet Large 4ct

GUDID 00810000310265

Silicone sheets for scar management

HRA PHARMA AMERICA, INC.

Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar management dressing, single-use, non-sterile Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use Scar-management dressing, single-use
Primary Device ID00810000310265
NIH Device Record Key96aa77f4-2a7d-4504-bec1-028c5739daa5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMederma Medical Grade Silicone Scar Sheet Large 4ct
Version Model Number00810000310265
Company DUNS081160441
Company NameHRA PHARMA AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810000310265 [Primary]

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 Date2022-08-16
Device Publish Date2022-08-08

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