AccessGUDID - DEVICE: LARGE UNI-CLIP® (10381780041986)

GUDID

Device Identifier (DI) Information

Brand Name: LARGE UNI-CLIP®
Version or Model: 119990ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NEWDEAL

Primary DI Number: 10381780041986
Issuing Agency: GS1
Commercial Distribution End Date: October 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The sterilisation container is used in the transport and the sterilization of the LARGE UNI-CLIP® associated instruments and non sterile implants. It includes one base with reference 119992ND, one lid with reference 119991ND one cylinder with reference 119993ND, one tray with reference 119994ND, one insert with reference 119995ND and one base with reference 119996ND. 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: 702fd94f-d5e0-42e4-bf30-8cb6c2728483
Public Version Date: April 04, 2023
Public Version Number: 7
DI Record Publish Date: May 26, 2017