Catalog Number

SEB2503PUS

Brand Name

Sebacia Microparticles

Version/Model Number

SEB-250-3P-US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181518,K181518

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

63936dfc-15f1-4eb1-8879-81b9e4b9ac0c

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-