AccessGUDID - DEVICE: EndoPilot apex cable set (04260482990282)

GUDID

Device Identifier (DI) Information

Brand Name: EndoPilot apex cable set
Version or Model: EDP2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 109 2311
Company Name: Schlumbohm GmbH & Co. KG

Primary DI Number: 04260482990282
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343831731 *Terms of Use

Device Description: Apex-cable-Set for Endopilot, consist of: 1x measuring cable with plug; 1x lip clip; 1x cap for lip contact; 1x cable for file clamp; 1x file clamp, dismountable; 1x Bushing for lip-clip cable-socket

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 [?]
K202906	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant
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: 2384df8d-de39-4857-bba0-0a1df5d95d78
Public Version Date: June 08, 2021
Public Version Number: 1
DI Record Publish Date: May 31, 2021