Sebacia Microparticles SEB2503PUS

GUDID G256SEB2503PUS1

Sebacia Microparticles Box of 9 vials

Coronado Aesthetics, LLC

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Primary Device ID	G256SEB2503PUS1
NIH Device Record Key	63936dfc-15f1-4eb1-8879-81b9e4b9ac0c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sebacia Microparticles
Version Model Number	SEB-250-3P-US
Catalog Number	SEB2503PUS
Company DUNS	118668178
Company Name	Coronado Aesthetics, LLC
Device Count	9
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter
Total Volume	3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G256SEB2503PUS0 [Unit of Use]
HIBCC	G256SEB2503PUS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181518

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-10-12
Device Publish Date	2022-10-04