AccessGUDID - DEVICE: Lock-On Saliva Ejector Valve Tips (00723896009932)

GUDID

Device Identifier (DI) Information

Brand Name: Lock-On Saliva Ejector Valve Tips
Version or Model: 70-39775
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-39775
Company Name: PRACTICON, INC.

Primary DI Number: 00723896009932
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Tired of the inconvenience and expense of saliva ejector valve tips that pull off during a procedure or get lost? Upgrade to our Lock-On Saliva Ejector Valve Tips. For no more than the cost of regular silicone SE tips, Lock-Ons fit your existing valves and stay put under tension. Installing them takes only a few seconds. Tips fit all standard saliva ejector valves and adapters. Bright blue color identifies them at a glance. Silicone and Viton® ring construction is fully sterilizable up to 375°F. Three blue tips and six locking rings per pack.

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:	No
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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38759	Dental suction system cannula, reusable	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 made of metal or plastic materials that can be sterilized. This is a reusable 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: 37716d13-f10b-409a-b68d-13beb1d37da5
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 18, 2018