Vivera Pharmaceuticals

GUDID 00372380000315

A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

VIVERA PHARMACEUTICALS, INC.

Scar management dressing, reusable
Primary Device ID00372380000315
NIH Device Record Key784670a2-18ae-4f44-b6f8-b18306fed5c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivera Pharmaceuticals
Version Model NumberSzosil
Company DUNS081244342
Company NameVIVERA PHARMACEUTICALS, 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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com
Phone949-234-6161
Emailregulatory@viverapharma.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100372380000315 [Primary]
GS100372380000339 [Unit of Use]

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 Date2021-09-27
Device Publish Date2021-09-17

On-Brand Devices [Vivera Pharmaceuticals ]

00372380000322A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be app
00372380000315A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be app

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