AccessGUDID - DEVICE: Sebacia Microparticles (G256SEB2503PUS1)

GUDID

Device Identifier (DI) Information

Brand Name: Sebacia Microparticles
Version or Model: SEB-250-3P-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SEB2503PUS
Company Name: Coronado Aesthetics, LLC

Primary DI Number: G256SEB2503PUS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 9
Labeler D-U-N-S® Number*: 118668178 *Terms of Use

Device Description: Sebacia Microparticles Box of 9 vials

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62071	Photothermal therapy gel	A non-sterile, topically-applied gel/suspension intended to be used in conjunction with a lamp/laser to treat an inflammatory skin disorder (e.g., rosacea, psoriasis, acne) as part of photothermal therapy (PTT). It contains micro-/nano-particles intended to be delivered to a dermal structure (e.g., sebaceous glands, hair follicles), whereby absorption of light causes them to heat up (photothermal heating) to produce a therapeutic effect. It is intended to be used by a healthcare professional in a clinical setting. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument
QCY	Laser Absorbing Particles

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

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