AccessGUDID - DEVICE: PureLife Dental (D79011430011)

GUDID

Device Identifier (DI) Information

Brand Name: PureLife Dental
Version or Model: 1143001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1143001
Company Name: PURELIFE, LLC

Primary DI Number: D79011430011
Issuing Agency: HIBCC
Commercial Distribution End Date: July 01, 2021
Device Count: 100
Labeler D-U-N-S® Number*: 828690904 *Terms of Use

Device Description: White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comfort, Specially-designed tip ensures optimal suction

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:	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
DYN	Mouthpiece, Saliva Ejector

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: bfdc5a15-93a0-4a92-9341-57b552ec7f95
Public Version Date: January 16, 2023
Public Version Number: 2
DI Record Publish Date: July 01, 2021