AccessGUDID - DEVICE: ROEKO GuttaFlow®2 (E165600137192)

GUDID

Device Identifier (DI) Information

Brand Name: ROEKO GuttaFlow®2
Version or Model: 60013719
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60013719
Company Name: Coltène/Whaledent GmbH + Co. KG

Primary DI Number: E165600137192
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 315494443 *Terms of Use

Device Description: ROEKO GuttaFlow®2 Mixing tips

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
DZN	Instruments, Dental Hand

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: 74642a78-fba5-4182-be53-cb65d76467bb
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: September 22, 2022