AccessGUDID - DEVICE: Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V (00850012210009)

GUDID

Device Identifier (DI) Information

Brand Name: Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V
Version or Model: HC 80TT-120-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HC 80TT-120-001
Company Name: STERILUCENT, INC.

Primary DI Number: 00850012210009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005634969 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	No
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?
40567	Hydrogen peroxide gas sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using hydrogen peroxide (H2O2) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It includes a treatment chamber where the devices to be sterilized are placed, usually after cleaning of gross debris, and a means to introduce the gas into the chamber; it is not intended to generate a gas plasma. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLR	Sterilizer, Chemical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190005	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
No Device Sizes

Device Record Status

Public Device Record Key: f88961c0-953f-452c-aaf7-010ac999ee6f
Public Version Date: May 06, 2020
Public Version Number: 1
DI Record Publish Date: April 28, 2020