AccessGUDID - DEVICE: NA (00724995150488)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: AX086010001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AX086010001
Company Name: Steris Mexico, S. de R.L. de C.V.

Primary DI Number: 00724995150488
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 813116209 *Terms of Use

Device Description: The Atlas Loading Car 26-inch x 26-inch x 61-inch is designed for use with the sterilization systems.

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
FLE	Sterilizer, steam

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 61 Inch
Width: 26 Inch
Height: 26 Inch

Device Record Status

Public Device Record Key: 378bbf56-285c-4b04-9c8c-fea5096bf57f
Public Version Date: November 24, 2020
Public Version Number: 6
DI Record Publish Date: September 14, 2016