AccessGUDID - DEVICE: STERILINK™ (08800066500306)

GUDID

Device Identifier (DI) Information

Brand Name: STERILINK™
Version or Model: 110V
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Plasmapp Co.,Ltd.

Primary DI Number: 08800066500306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695798956 *Terms of Use

Device Description: The STERLINK plus with STERPACK plus sterilization is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK plus can sterilize: 1.Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors 2.Medical devices with a single stainless-steel lumen with: - STERPACK plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter - STERLOAD: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter

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):	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?
36305	Plasma sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using vapours (or gases) in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and then packed; a means to introduce the vapour [e.g., hydrogen peroxide (H2O2)] into the chamber; electrodes that are activated to convert the vapour into plasma; a radio-frequency generator; and cycle controls. The device is available in 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 [?]
K223015	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: c41d4b4d-1290-444c-93b7-b6752e4e05b2
Public Version Date: July 21, 2023
Public Version Number: 1
DI Record Publish Date: July 13, 2023