AccessGUDID - DEVICE: No-Splash Air-Water Syringe Tips (00723896009987)

GUDID

Device Identifier (DI) Information

Brand Name: No-Splash Air-Water Syringe Tips
Version or Model: 70-42611
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-42611
Company Name: PRACTICON, INC.

Primary DI Number: 00723896009987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 150
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: an infection control shield built right in that reduces splash-back and cross contamination! The non-removable shields adjust forward or backward to accommodate varying working positions and water pressures.Does not interfere with working field or visibility Aids in cheek retraction Besides their protection value, No-Splash tips are precision-molded to deliver powerful dry air, water and mist functions without leaking. Fit all standard 3-way A-W syringes using quick change-style metal tips-no adapter required. 150 tips per dispenser box in three assorted colors.

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?
45131	Dental delivery system irrigation handpiece	A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECB	Unit, Syringe, Air And/Or Water

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: ebee35fa-618d-4bbb-9339-5153d3114be8
Public Version Date: August 20, 2018
Public Version Number: 1
DI Record Publish Date: July 18, 2018