AccessGUDID - DEVICE: ECOtip HVE Tips Polka Dot (00723896010747)

GUDID

Device Identifier (DI) Information

Brand Name: ECOtip HVE Tips Polka Dot
Version or Model: 10410006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-08313
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Made from renewable, sustainable paper, ECOtip Earth-Friendly High Volume Evacuator Tips are the high-performance alternative to plastics. ECOtip is engineered and tested to provide outstanding stiffness, durability, and function. Food-grade coating eliminates moisture absorption and fraying during use. Tips fit standard HVE valves. Made under strict ISO standards from FDA-approved materials.

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):	No
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
EHZ	Evacuator, Oral Cavity

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: 4e7bc362-2c6f-4abe-9929-b475d6f4f651
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 19, 2018