AccessGUDID - DEVICE: ROEKO Aspirator tips (E1654610480)

GUDID

Device Identifier (DI) Information

Brand Name: ROEKO Aspirator tips
Version or Model: 461048
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 461048
Company Name: Coltène/Whaledent GmbH + Co. KG

Primary DI Number: E1654610480
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315494443 *Terms of Use

Device Description: No description.

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?
37434	Dental suction system cannula, single-use	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	Catheter And Tip, Suction

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
Device Size Text, specify: Tip-opening 4.8 mm
Outer Diameter: 6.5 Millimeter

Device Record Status

Public Device Record Key: d23ca325-9947-4561-b281-ae567bec1422
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2016