AccessGUDID - DEVICE: STERLINK™ (08800066500030)

GUDID

Device Identifier (DI) Information

Brand Name: STERLINK™
Version or Model: STERLOAD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Plasmapp Co.,Ltd.

Primary DI Number: 08800066500030
Issuing Agency: GS1
Commercial Distribution End Date: November 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 695798956 *Terms of Use

Device Description: sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus. The STERLOAD is group of sterilant cassette products which are designed to be used only by STERLINK™ sterilizer products, low temperature plasma sterilization system. The STERLOAD is supposed to be inserted in the STERLINK™ chamber to proceed sterilization process.

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):	No
Over the Counter (OTC):	Yes
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?
44835	Hydrogen peroxide device sterilant	A gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLR	Sterilizer, Chemical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212200	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
Storage Environment Humidity: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b17b6c2b-43a4-4a31-a274-a1cc65d94a51
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: November 26, 2021