szosil medical grade silicone sheeting gel for scars

GUDID 10372380000008

VIVERA PHARMACEUTICALS, INC.

Scar-management dressing, single-use
Primary Device ID10372380000008
NIH Device Record Key80709615-f469-458e-8030-2891c491b5a6
Commercial Distribution StatusIn Commercial Distribution
Brand Nameszosil medical grade silicone sheeting gel for scars
Version Model Number1
Company DUNS081244342
Company NameVIVERA PHARMACEUTICALS, INC.
Device Count2
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100372380000001 [Unit of Use]
GS110372380000008 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-16
Device Publish Date2019-08-23

Devices Manufactured by VIVERA PHARMACEUTICALS, INC.

10372380000008 - szosil medical grade silicone sheeting gel for scars2024-02-16
10372380000008 - szosil medical grade silicone sheeting gel for scars2024-02-16
00372380000384 - Vivera Pharmaceuticals, Inc2022-07-11 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th
00372380000315 - Vivera Pharmaceuticals 2021-09-27 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th
00372380000322 - Vivera Pharmaceuticals 2021-09-27 A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for th
00372380000018 - szosil medical grade silicone gel sheeting for scar2019-09-30
00372380000025 - szosil silicone stick2019-09-30
00372380000032 - szosil skin repair serum2019-09-30

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