AccessGUDID - DEVICE: Apex ID (08809455602089)

GUDID

Device Identifier (DI) Information

Brand Name: Apex ID
Version or Model: Apex ID Main Body
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 972-0085
Company Name: META SYSTEMS CO., LTD.

Primary DI Number: 08809455602089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687503532 *Terms of Use

Device Description: Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals.

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?
16355	Endodontic apex locator	A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQY	Locator, Root Apex

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112153	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: 8cf74977-9ea6-41ee-a3a3-abef01c45f42
Public Version Date: January 07, 2025
Public Version Number: 1
DI Record Publish Date: December 30, 2024