AccessGUDID - DEVICE: NA (00724995150839)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: CM53
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CM53
Company Name: Corporation Steris Canada

Primary DI Number: 00724995150839
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202659140 *Terms of Use

Device Description: The One Level General Purpose Vision Rack is designed to be used in the washer disinfector for the efficient cleaning, rinsing, drying and intermediate Level disinfection of two full size surgical instrument trays or miscellaneous hard goods.

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?
62151	Sterilizer/disinfector rack	A non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEC	Disinfector, medical devices

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 0a7ca7a6-cf4c-4852-8a4f-a889a83c8083
Public Version Date: January 28, 2021
Public Version Number: 4
DI Record Publish Date: September 13, 2016