AccessGUDID - DEVICE: VERIFY SIXCESS (10724995154735)

GUDID

Device Identifier (DI) Information

Brand Name: VERIFY SIXCESS
Version or Model: PCC072
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCC072
Company Name: STERIS CORPORATION

Primary DI Number: 10724995154735
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 040469731 *Terms of Use

Device Description: The VERIFY SixCess MF4 STEAM Emulating Indicator is a cycle-specific indicator monitoring all critical parameters of a steam sterilization cycle.

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?
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, physical/chemical sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep dry and away from sunlight. Do Not store near heat, moisture, oxidizing agents, acids/alkalis, or cleaning/disinfecting agents.
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 16 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Yard

Device Record Status

Public Device Record Key: ff9d8746-5141-4ec0-9eb2-6658018ddf6d
Public Version Date: February 21, 2025
Public Version Number: 4
DI Record Publish Date: April 19, 2019