AccessGUDID - DEVICE: NA (00724995176730)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: FD257
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FD257
Company Name: Corporation Steris Canada

Primary DI Number: 00724995176730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202659140 *Terms of Use

Device Description: The RAS 12 Long Rack is designed to enable the mechanical cleaning, rinsing, and disinfection of up to 12 robotic-assisted surgery instruments in the AMSCO 7052HP and or 7053HP Single Chamber Washer Disinfectors.

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?
61723	Luminal device flushing tubing set, reusable	A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NVE	Washer, cleaner, automated, endoscope

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
No Device Sizes

Device Record Status

Public Device Record Key: 4fd82daf-f1f0-426c-b6b2-3e9a1b1aa766
Public Version Date: July 16, 2024
Public Version Number: 5
DI Record Publish Date: September 09, 2019