AccessGUDID - DEVICE: Mixing Tips Yellow 100 (EBIB019551)

GUDID

Device Identifier (DI) Information

Brand Name: Mixing Tips Yellow 100
Version or Model: 01955
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01955
Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Primary DI Number: EBIB019551
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316133664 *Terms of Use

Device Description: Mixing tips to attach to a cartridge. The cartridge is filled with 2-component impression silicone, dental cement or similar. The mixing tip has a spiral inside with which the 2 components can be mixed and comes out mixed on the front. Used in dentistry.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
58399	Dental material mixing nozzle	A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EID	Syringe, Restorative And Impression Material

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: 72ffed19-e145-4c06-be88-72f7727a6ac1
Public Version Date: June 29, 2023
Public Version Number: 3
DI Record Publish Date: June 23, 2020