AccessGUDID - DEVICE: Endo-Express (00766054001218)

GUDID

Device Identifier (DI) Information

Brand Name: Endo-Express
Version or Model: 5520-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5520-00
Company Name: ESSENTIAL DENTAL SYSTEMS, INC.

Primary DI Number: 00766054001218
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 101147171 *Terms of Use

Device Description: Endo-Express E Type Mini Latch Head Contra Angle

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):	Yes
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?
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, contra- and right-angle attachment, dental

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 4306be63-daad-496f-b8fc-e277e7e146c9
Public Version Date: November 23, 2023
Public Version Number: 2
DI Record Publish Date: July 10, 2020