AccessGUDID - DEVICE: SYSTEM 1 endo (00724995170554)

GUDID

Device Identifier (DI) Information

Brand Name: SYSTEM 1 endo
Version or Model: 1 endo
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P6900
Company Name: Corporation Steris Canada

Primary DI Number: 00724995170554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202659140 *Terms of Use

Device Description: SYSTEM 1 endo Liquid Chemical Sterilant Processing System with Touchscreen is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices.

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?
36253	Liquid sterilant sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products by immersion in sterilant solutions [e.g., formaldehyde, glutaraldehyde, ortho-phthalaldehyde (OPA) also known as phthaldehyde]; it is typically used for products sensitive to high temperature and humidity and not damaged by sterilant solution. It typically includes a treatment chamber with a container for liquid sterilant and where trays with the devices to be sterilized are manually placed, usually after cleaning of gross debris; a mechanism to introduce and/or circulate the liquid into the chamber; and controls to regulate procedure time.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MED	Sterilant, medical devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182827	000
K190104	000
K191343	000
K192929	000
K210737	000
K211607	000
K222615	000
K230582	000
K232914	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: 32d17518-607e-4f35-950d-9adccacb0fde
Public Version Date: November 04, 2024
Public Version Number: 6
DI Record Publish Date: October 04, 2019