Silicone for Scar Management 701

GUDID G420701

Ensil Fabric, 8" x 8"

Gottfried Medical, Inc.

Scar management dressing, reusable
Primary Device IDG420701
NIH Device Record Key51381368-81f7-4dc8-b8b5-a09e0d941f10
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone for Scar Management
Version Model Number701
Catalog Number701
Company DUNS038706180
Company NameGottfried Medical, 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 Datetrue
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
HIBCCG420701 [Primary]

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 Date2023-08-23
Device Publish Date2023-08-15

On-Brand Devices [Silicone for Scar Management]

G420710Ensil Fabric, Linear Foot
G420701Ensil Fabric, 8" x 8"

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