Sebacia Microparticles SEB2503PUS

GUDID G256SEB2503PUS1

Sebacia Microparticles Box of 9 vials

Coronado Aesthetics, LLC

Photothermal therapy gel
Primary Device IDG256SEB2503PUS1
NIH Device Record Key63936dfc-15f1-4eb1-8879-81b9e4b9ac0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSebacia Microparticles
Version Model NumberSEB-250-3P-US
Catalog NumberSEB2503PUS
Company DUNS118668178
Company NameCoronado Aesthetics, LLC
Device Count9
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG256SEB2503PUS0 [Unit of Use]
HIBCCG256SEB2503PUS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-12
Device Publish Date2022-10-04

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