AccessGUDID - DEVICE: The Glider™ Dental Treatment Station (00850309007770)

GUDID

Device Identifier (DI) Information

Brand Name: The Glider™ Dental Treatment Station
Version or Model: 90-2148
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ASI MEDICAL, INC.

Primary DI Number: 00850309007770
Issuing Agency: GS1
Commercial Distribution End Date: November 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 808695159 *Terms of Use

Device Description: Integrated delivery system with up to two handpiece connections, dual air/water syringes and titanium saliva ejector and high-volume evacuator. Delivery system features programmable electro-mechanically adjusted height to allow for sit down to stand up procedures and Wilsonart solid surface worktop and heavy duty 3” casters. Storage includes two side rails for accessory brackets, saline bag hooks, and sharps containers. Includes back rail with two storage tubs.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60930	Dental delivery system instrument unit, electric	A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110481	000

Device Exempt from Premarket Submission: No 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: 77221126-8312-47ae-9831-c4c3eeff8494
Public Version Date: November 30, 2022
Public Version Number: 1
DI Record Publish Date: November 22, 2022