AccessGUDID - DEVICE: QWIX® (10381780041849)

GUDID

Device Identifier (DI) Information

Brand Name: QWIX®
Version or Model: 119941ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780041849
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The screw combined base is used in the transport and the sterilization of the QWIX® associated instruments. It is composed of one base with six silicone bumpers to securely maintain the devices, one lower screw rack and one upper screw rack and one silicone carpet with reference 119943ND. The transport and sterilization containers are not intended to maintain sterility.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	TRAY, SURGICAL, INSTRUMENT

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 17ae3bbf-fb55-4081-9b63-cd4c26e3ac7f
Public Version Date: January 31, 2025
Public Version Number: 8
DI Record Publish Date: May 26, 2017